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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Emergency, Manual (Resuscitator)
510(k) Number K883434
Device Name AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR)
Applicant
Ambu, Inc.
7476 New Ridge Rd-Ste D
Hanover,  MD  21076
Applicant Contact FRANK HOMA
Correspondent
Ambu, Inc.
7476 New Ridge Rd-Ste D
Hanover,  MD  21076
Correspondent Contact FRANK HOMA
Regulation Number868.5915
Classification Product Code
BTM  
Date Received08/15/1988
Decision Date 09/14/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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