FDA 510(k) Applications for Medical Device:
Oximeter, Tissue Saturation
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K094030 | CAS MEDICAL SYSTEMS, INC. |
44 EAST INDUSTRIAL RD. | BRANFORD | CT | 06405 |
| K112820 | CAS MEDICAL SYSTEMS, INC. |
44 EAST INDUSTRIAL RD. | BRANFORD | CT | 06405 |
| K061960 | CAS MEDICAL SYSTEMS, INC. |
44 EAST INDUSTRIAL RD. | BRANFORD | CT | 06405 |
| K123700 | CAS MEDICAL SYSTEMS, INC. |
44 EAST INDUSTRIAL RD. | BRANFORD | CT | 06405 |
| K133879 | CAS MEDICAL SYSTEMS, INC. |
44 EAST INDUSTRIAL RD. | BRANFORD | CT | 06405 |
| K143675 | CAS MEDICAL SYSTEMS, INC. |
44 EAST INDUSTRIAL RD. | BRANFORD | CT | 06405 |
| K180003 | CAS Medical Systems, Inc. |
44 East Industrial Road | Branford | CT | 06405 |
| K190270 | CAS Medical Systems, Inc. |
44 East Industrial Road | Branford | CT | 06405 |
| K091452 | CAS MEDICAL SYSTEMS, INC. |
44 EAST INDUSTRIAL RD. | BRANFORD | CT | 06405 |
| K171245 | Christie Medical Holdings, Inc. |
3175 Lenox Park Boulevard, Suite 200 | Memphis | TN | 38115 |
| K182868 | Covidien llc |
6135 Gunbarrel Avenue | Boulder | CO | 80301 |
| K211561 | Covidien, llc |
6135 Gunbarrel Avenue | Boulder | CO | 80301 |
| K240596 | Edwards Lifesciences |
One Edwards Way | Irvine | CA | 92614 |
| K223651 | Edwards Lifesciences, LLC |
One Edwards Way | Irvine | CA | 92614 |
| K230612 | Edwards Lifesciences, LLC |
One Edwards Way | Irvine | CA | 92614 |
| K203490 | Edwards Lifesciences, LLC |
One Edwards Way | Irvine | CA | 92614 |
| K143219 | Hamamatsu Photonics K.K. |
812 Joko-cho | Hamamatsu City | 431-3196 | |
| K162117 | Hamamatsu Photonics K.K. |
812 Joko-cho, Higashi-ku | Hamamatsu City | 431-3196 | |
| K963903 | HUTCHINSON TECHNOLOGY, INC. |
40 WEST HIGHLAND PARK | HUTCHINSON | MN | 55350 |
| K103613 | HUTCHINSON TECHNOLOGY, INC. |
40 WEST HIGHLAND PARK DR. NE | HUTCHINSON | MN | 55350 |
| K061619 | HUTCHINSON TECHNOLOGY, INC. |
40 WEST HIGHLAND PARK | HUTCHINSON | MN | 55350 |
| K100915 | HUTCHINSON TECHNOLOGY, INC. |
40 WEST HIGHLAND PARK DR. NE | HUTCHINSON | MN | 55350 |
| K012759 | HUTCHINSON TECHNOLOGY, INC. |
40 WEST HIGHLAND PARK | HUTCHINSON | MN | 55350 |
| K053618 | HUTCHINSON TECHNOLOGY, INC. |
40 WEST HIGHLAND PARK | HUTCHINSON | MN | 55350 |
| K023938 | HUTCHINSON TECHNOLOGY, INC. |
40 WEST HIGHLAND PARK | HUTCHINSON | MN | 55350 |
| K042020 | HUTCHINSON TECHNOLOGY, INC. |
40 WEST HIGHLAND PARK | HUTCHINSON | MN | 55350 |
| K161237 | HYPERMED IMAGING, INC. |
8700 TRAIL LAKE DR WEST, SUITE 200 | MEMPHIS | TN | 38125 |
| K061848 | HYPERMED, INC. |
11 MYSTIC AVE. | WINCHESTER | MA | 01890-2920 |
| K073656 | HYPERMED, INC. |
11 MYSTIC AVE. | WINCHESTER | MA | 01890-2920 |
| K232385 | ISS Medical, Inc. |
1602 Newton Drive | Champaign | IL | 61822 |
| K201976 | Kent Imaging |
804B 16th Ave SW | Calgary | t2r 0s9 | |
| K240601 | Kent Imaging Inc |
Suite 300, 1210 8 Street SW | Calgary | T2R 1L3 | |
| K113507 | KENT IMAGING INC. |
1440, 720- 13TH AVENUE SW | CALGARY | T2R 1M5 | |
| K163070 | KENT IMAGING INC. |
1440, 720- 13TH AVENUE SW | CALGARY | T2R 1M5 | |
| K243324 | Masimo Corporation |
52 Discovery | Irvine | CA | 92618 |
| K160526 | MASIMO CORPORATION |
52 DISCOVERY | IRVINE | CA | 92618 |
| K162603 | MASIMO CORPORATION |
52 DISCOVERY | IRVINE | CA | 92618 |
| K182429 | Masimo Corporation |
52 Discovery | Irvine | CA | 92618 |
| K201432 | Masimo Corporation |
52 Discovery | Irvine | CA | 92618 |
| K214072 | Masimo Corporation |
52 Discovery | Irvine | CA | 92618 |
| K190334 | MIMOSA Diagnostics Inc |
1 Yonge St Suite 201 | Toronto | M5E1E5 | |
| K181623 | Modulated Imaging, Inc. |
17151 Gillette Ave | Irvine | CA | 92604 |
| K153426 | MODULATED IMAGING, INC. |
17151 GILLETTE AVE | IRVINE | CA | 92604 |
| K112826 | MOOR INSTRUMENTS LTD. |
MILLWEY | AXMINSTER, DEVON | EX135HU | |
| K151305 | NONIN MEDICAL INC. |
13700 1ST AVENUE NORTH | PLYMOUTH | MN | 55441 |
| K113215 | NONIN MEDICAL, INC. |
13700 1ST AVE, NORTH | Plymouth | MN | 55441 |
| K102715 | NONIN MEDICAL, INC. |
13700 1ST AVE. NORTH | PLYMOUTH | MN | 55441-5443 |
| K090807 | NONIN MEDICAL, INC. |
13700 1ST AVE. NORTH | PLYMOUTH | MN | 55441-5443 |
| K190560 | Nonin Medical, Inc. |
13700 1st Avenue North | Plymouth | MN | 55441 |
| K241393 | ODI Medical AS |
Karenslyst AllΘ 8A | Oslo | 0278 | |
| K093923 | OR-NIM MEDICAL LTD. |
1 YODFAT ST | LOD | 71291 | |
| K100875 | OR-NIM MEDICAL LTD. |
1 YODFAT ST | LOD | 71291 | |
| K073407 | OR-NIM MEDICAL LTD. |
2001 PENNSYLVANIA AVE. NW | WASHINGTON | DC | 20006 |
| K113656 | REFLECTANCE MEDICAL INC |
116 FLAUNDERS ROAD, | WESTBOROUGH | MA | 01581 |
| K122645 | REFLECTANCE MEDICAL INC |
116 FLAUNDERS ROAD, | WESTBOROUGH | MA | 01581 |
| K130079 | REFLECTANCE MEDICAL INC |
116 FLAUNDERS ROAD, | WESTBOROUGH | MA | 01581 |
| K133923 | REFLECTANCE MEDICAL INC |
116 FLAUNDERS ROAD, | WESTBOROUGH | MA | 01581 |
| K141496 | REFLECTANCE MEDICAL, INC. |
116 FLANDERS ROAD, SUITE 1000 | WESTBOROUGH | MA | 01581 |
| K080769 | SOMANETICS CORP. |
1653 EAST MAPLE RD. | TROY | MI | 48083-4208 |
| K082327 | SOMANETICS CORP. |
1653 EAST MAPLE RD. | TROY | MI | 48083-4208 |
| K051274 | SOMANETICS CORP. |
1653 EAST MAPLE RD. | TROY | MI | 48083-4208 |
| K091224 | SOMANETICS CORP. |
1653 EAST MAPLE RD. | TROY | MI | 48083-4208 |
| K192322 | Spectros Corporation |
274 E Hamilton Ave Suite H | Campbell | CA | 95008 |
| K081233 | SPECTROS CORPORATION |
9433 SOUTH MORNING GLORY LANE | HIGHLANDS RANCH | CO | 80130 |
| K040684 | SPECTROS CORPORATION |
4370 ALPINE ROAD | PORTOLA VALLEY | CA | 94028 |
| K133983 | VIOPTIX INC. |
3722 AVE. SAUSALITO | IRVINE | CA | 92606 |
| K191676 | ViOptix, Inc. |
39655 Eureka Drive | Newark | CA | 94560 |
| K221010 | ViOptix, Inc. |
39655 Eureka Drive | Newark | CA | 94560 |
| K163472 | VIOPTIX, INC. |
39655 EUREKA DRIVE | NEWARK | CA | 94560 |
| K233488 | ViOptix, Inc. |
39655 Eureka Drive | Newark | CA | 94560 |
| K250519 | ViOptix, Inc. |
39655 Eureka Drive | Newark | CA | 94560 |
| K141234 | VIOPTIX, INC. |
3722 AVE. SAUSALITO | IRVINE | CA | 92606 |
| K042657 | VIOPTIX, INC. |
3722 AVE. SAUSALITO | IRVINE | CA | 92606 |
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