FDA 510(k) Applications for Medical Device:
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
FDA 510(k) Number |
Applicant |
Address |
City / Country |
State / Province |
Postal Code |
K102377 |
A PLUS MEDICAL |
5431 AVENIDA ENCINAS
| CARLSBAD |
CA |
92008 |
K040991 |
AMBU, INC. |
611 NORTH HAMMONDS FERRY ROAD
| LINTHICUM |
MD |
21090-1356 |
K140370 |
BESMED HEALTH BUSINESS CORP. |
NO.5, LANE116, WU-KONG 2ND RD
| NEW TAIPEI CITY, WU-KU DISTRICT |
|
TW |
K992101 |
CARADYNE, LTD. |
6329 W. WATERVIEW CT.
| MCCORDSVILLE |
IN |
46055 |
K000959 |
CARADYNE, LTD. |
6329 W. WATERVIEW CT.
| MCCORDSVILLE |
IN |
46055 |
K172284 |
DRW Medical, LLC |
811 Lincoln Drive
| Brookhaven |
PA |
19015 |
K003497 |
ENGINEERED MEDICAL SYSTEMS |
6329 W. WATERVIEW CT.
| MCCORDSVILLE |
IN |
46055 |
K201666 |
Flexicare Medical Limited |
Cynon Valley Business Park
| Mountain Ash |
|
cf45 4er |
K122627 |
GALEMED CORP. |
29201 VIA NORTE
| TEMECULA |
CA |
92591 |
K180510 |
Instrumentation Industries, Inc. |
2990 Industrial Blvd.
| Bethel Park |
PA |
15102 |
K081778 |
INSTRUMENTATION INDUSTRIES, INC. |
2990 INDUSTRIAL BLVD.
| BETHEL PARK |
PA |
15102 |
K122077 |
INTERSURGICAL, INC. |
417 ELECTRONICS PKWY.
| LIVERPOOL |
NY |
13088 |
K961318 |
INTERTECH RESOURCES, INC. |
5100 TICE ST.
| FT. MYERS |
FL |
33905 |
K954486 |
MERCURY MEDICAL |
11300-A 49TH ST. NORTH
| CLEARWATER |
FL |
34622-4800 |
K110119 |
NEOFORCE GROUP INC |
35 COMMERCE DRIVE
| IVYLAND |
PA |
18974 |
K973347 |
SPIRACLE TECHNOLOGY |
16520 HARBOR BLVD., UNIT D
| FOUNTAIN VALLEY |
CA |
92708 |
K120118 |
VENTLAB CORP. |
155 BOYCE DRIVE
| MOCKSVILLE |
NC |
27028 |
K050309 |
VIASYS MEDSYSTEMS |
100 CHADDICK DR.
| WHEELING |
IL |
60090 |
K022402 |
VITAL SIGNS, INC. |
20 CAMPUS RD.
| TOTOWA |
NJ |
07512 |
K103639 |
VORTRAN MEDICAL TECHNOLOGY 1, INC. |
21 GOLDEN LAND COURT
| SACRAMENTO |
CA |
95834 |
K182292 |
VORTRAN Medical Technology 1, Inc. |
21 Goldenland Court, Suite 100
| Sacramento |
CA |
95834 |
K153733 |
VORTRAN MEDICAL TECHNOLOGY 1, INC. |
21 GOLDENLAND COURT, #100
| SACRAMENTO |
CA |
95834 |
K143148 |
Westmed, Inc. |
5580 S. Nogales Hwy.
| Tucson |
AZ |
85706 |
|
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