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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, Powered (Resuscitator)
510(k) Number K991785
Device Name MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR
Applicant
Instrumentation Industries, Inc.
2990 Industrial Blvd.
Bethel Park,  PA  15102
Applicant Contact TRICIA WOOD
Correspondent
Instrumentation Industries, Inc.
2990 Industrial Blvd.
Bethel Park,  PA  15102
Correspondent Contact TRICIA WOOD
Regulation Number868.5925
Classification Product Code
BTL  
Date Received05/25/1999
Decision Date 08/17/1999
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
Recalls CDRH Recalls
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