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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