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510(k) K830818

ASAHI BLOOD/PLASMA PUMP #ABP-01A & by Parker Hannifin Corp. — Product Code FIR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1983
Date Received
March 15, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Blood, Extra-Luminal
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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  • K831402 — PRESSURE MONITOR & CONTROL UNIT APC-02A (August 8, 1983)
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Other clearances for product code FIR

  • K961137 — ATI PLASMA PUMP (PP-04) (June 14, 1996)
  • K831953 — INFUSION PUMP (July 19, 1983)
  • K821139 — SPS-SINGLE PATIENT SYSTEM (May 10, 1982)
  • K780410 — BLOOD PUMP-MODE S10K (May 3, 1978)
  • K771705 — RS-7800 MINIPUMP (October 4, 1977)
  • K761050 — HEPARIN PUMP (December 30, 1976)