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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 K040991
Device Name AMBU DISPOSABLE PRESSURE MANOMETER
Applicant
AMBU, INC.
611 NORTH HAMMONDS FERRY ROAD
LINTHICUM,  MD  21090 -1356
Applicant Contact SANJAY PARIKH
Correspondent
AMBU, INC.
611 NORTH HAMMONDS FERRY ROAD
LINTHICUM,  MD  21090 -1356
Correspondent Contact SANJAY PARIKH
Regulation Number868.2600
Classification Product Code
CAP  
Date Received04/16/2004
Decision Date 07/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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