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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, airway pressure (includes gauge and/or alarm)
510(k) Number K003497
Device Name DISPOSABLE PRESSURE MONITOR
Applicant
ENGINEERED MEDICAL SYSTEMS
6329 W. WATERVIEW CT.
MCCORDSVILLE,  IN  46055
Applicant Contact PAUL DRYDEN
Correspondent
ENGINEERED MEDICAL SYSTEMS
6329 W. WATERVIEW CT.
MCCORDSVILLE,  IN  46055
Correspondent Contact PAUL DRYDEN
Regulation Number868.2600
Classification Product Code
CAP  
Date Received11/13/2000
Decision Date 11/30/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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