FDA 510(k) Applications for Medical Device:
Mixer, Breathing Gases, Anesthesia Inhalation
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K103317 | ATOM MEDICAL CORPORATION |
24301 WOODSAGE DRIVE | BONITA SPRINGS | FL | 34134 |
| K230987 | Baldus Sedation GmbH & Co. KG |
In der Langfuhr 32 | Bendorf | 56170 | |
| K222794 | Baldus Sedation GmbH & Co. KG |
In der Langfuhr 32 | Bendorf | 56170 | |
| K973646 | BIRD PRODUCTS CORP. |
1100 BIRD CENTER DR. | PALM SPRINGS | CA | 92262 |
| K092484 | CARDINAL HEALTH 207, INC. |
22745 SAVI RANCH PARKWAY | YORBA LINDA | CA | 92887 |
| K050381 | CS MEDICAL INC. |
4655 KIRKWOOD COURT | BOULDER | CO | 80301 |
| K221494 | DEHAS Medical Systems GmbH |
Wesloer Strabe 112 | Luebeck | 23568 | |
| K243917 | Fisher & Paykel Healthcare Ltd |
15 Maurice Paykel Place, East Tamaki | Auckland | 2013 | |
| K142291 | GENTEC (SHANGHAI) CORPORATION |
NO.1988 Yushu Road | Songjiang District | 201699 | |
| K990293 | HAMILTON MEDICAL, INC. |
3371 LENORA CHURCH RD. | SNELLVILLE | GA | 30039 |
| K960359 | HAMILTON MEDICAL, INC. |
P.O. BOX 30008 | RENO | NV | 89520 |
| K101286 | LINDE HEALTHCARE AB |
AGAVAGEN 54 | LIDINGO | SE 18181 | |
| K001609 | MALLARD MEDICAL, INC. |
20268 SKYPARK DR. | REDDING | CA | 96002 |
| K113232 | MAXTEC, INC. |
6526 SOUTH COTTONWOOD ST. | SALT LAKE CITY | UT | 84107 |
| K161718 | Maxtec, LLC |
2305 South 1070 West | Salt Lake City | UT | 84119 |
| K231895 | Maxtec, LLC |
2305 South 1070 West | Salt Lake City | UT | 84119 |
| K173205 | O-Two Medical Technologies Inc. |
45A Armthorpe Road | Brampton | L6T 5M4 | |
| K113687 | O-TWO MEDICAL TECHNOLOGIES, INC. |
7575 KIMBEL ST. | MISSISSAUGA | L5S 1C8 | |
| K202480 | Parker Hannifin |
245 Township Line Road | Hatfield | PA | 19440 |
| K241465 | Parker Hannifin Corporation |
245 Township Line Road | Hatfield | PA | 19440 |
| K051192 | PRAXAIR, INC. |
175 EAST PARK DR. | TONAWANDA | NY | 14150 |
| K090781 | PRECISION MEDICAL, INC. |
300 HELD DR. | NORTHAMPTON | PA | 18067 |
| K053232 | PRECISION MEDICAL, INC. |
300 HELD DR. | NORTHAMPTON | PA | 18067 |
| K992503 | SECHRIST INDUSTRIES, INC. |
4225 EAST LA PALMA | ANAHEIM | CA | 92807 |
| K974372 | SK MED |
16000 SHERMAN WAY #224 | VAN NUYS | CA | 91406 |
| K022864 | SK MED |
16000 SHERMAN WAY #224 | VAN NUYS | CA | 91406 |
| K031707 | SK MED |
16000 SHERMAN WAY #224 | VAN NUYS | CA | 91406 |
| K031860 | SK MED |
16000 SHERMAN WAY #224 | VAN NUYS | CA | 91406 |
| K081335 | TENACORE HOLDINGS, INC. |
647 EAST YOUNG ST. | SANTA ANA | CA | 92705 |
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