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 |
K223651 |
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 |
K201976 |
Kent Imaging |
804B 16th Ave SW
| Calgary |
|
t2r 0s9 |
K113507 |
KENT IMAGING INC. |
1440, 720- 13TH AVENUE SW
| CALGARY |
|
T2R 1M5 |
K163070 |
KENT IMAGING INC. |
1440, 720- 13TH AVENUE SW
| CALGARY |
|
T2R 1M5 |
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 |
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 |
K141234 |
VIOPTIX, INC. |
3722 AVE. SAUSALITO
| IRVINE |
CA |
92606 |
K042657 |
VIOPTIX, INC. |
3722 AVE. SAUSALITO
| IRVINE |
CA |
92606 |
|
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