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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 K881881
Device Name OXYGENATION CATHETER
Applicant
Ventech Healthcare Corp., Inc.
4295 International Blvd.
Norcross,  GA  30093
Applicant Contact JOHN SELLERS
Correspondent
Ventech Healthcare Corp., Inc.
4295 International Blvd.
Norcross,  GA  30093
Correspondent Contact JOHN SELLERS
Regulation Number868.5915
Classification Product Code
BTM  
Date Received05/04/1988
Decision Date 02/17/1989
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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