FDA 510(k), K880161, ACKRAD PEDIATRIC C.P.A.P. SYSTEM

FDA 510(k), K880161, ACKRAD PEDIATRIC C.P.A.P. SYSTEM

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510(K) Number: K880161
Device Name: ACKRAD PEDIATRIC C.P.A.P. SYSTEM
Manufacturer: ACKRAD LABORATORIES
Device Classification Name: attachment, breathing, positive end expiratory pressure
Regulation Number: 868.5965
Classification Product Code: BYE
Date Received: 01/13/1988
Decision Date: 03/04/1988
Regulation Medical Specialty: Anesthesiology
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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