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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 N. Hammonds Ferry Rd.
Linthicum,  MD  21090 -1356
Applicant Contact SANJAY PARIKH
Correspondent
Ambu, Inc.
611 N. Hammonds Ferry Rd.
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
Predetermined Change
Control Plan Authorized		 No
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