510(k) K930429

AID, CARDIOPULMONARY RESUSCITATION by Valley Forge Scientific Corp. — Product Code BTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1993
Date Received
January 26, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Emergency, Manual (Resuscitator)
Device Class
Class II
Regulation Number
868.5915
Review Panel
AN
Submission Type