Home / 510(k) Clearances / K923233

510(k) K923233

CARDIO-PAK LAPAROTOMY PACK by Cardio-Med-Associates, Inc. — Product Code FZH

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
March 20, 1993
Date Received
July 1, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Air Handling, Room
Device Class
Class II
Regulation Number
878.5070
Review Panel
SU
Submission Type

Other clearances by Cardio-Med-Associates, Inc.

  • K923231 — CARDIO-PAK BASIC PUMP PACK (July 9, 1993)

Other clearances for product code FZH

  • K875305 — MODEL UCA / SPEC SYSTEM UCA (January 27, 1988)
  • K871901 — ULTRAFLOW (June 1, 1987)
  • K770084 — OPERATING ROOM VENTILATOR (February 23, 1977)