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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 K012842
Device Name V*CARE MANUAL RESUSCITATOR
Applicant
Ventlab Corp.
2934 Hwy. 601 N.
Mocksville,  NC  27028
Applicant Contact MARGE WALLS-WALKER
Correspondent
Ventlab Corp.
2934 Hwy. 601 N.
Mocksville,  NC  27028
Correspondent Contact MARGE WALLS-WALKER
Regulation Number868.5915
Classification Product Code
BTM  
Date Received08/23/2001
Decision Date 09/18/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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