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510(k) K881631

BIODYNAMICS AUTOTRANSFUSION RESERVOIR by Biodynamics Corp. — Product Code CAC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1988
Date Received
April 14, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Autotransfusion
Device Class
Class II
Regulation Number
868.5830
Review Panel
CV
Submission Type

Other clearances by Biodynamics Corp.

  • K051675 — BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZER (March 16, 2006)
  • K884033 — BIODYNAMICS MODEL 200 BODY COMPOSITION ANALYZER (November 17, 1988)
  • K881968 — BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER (July 28, 1988)
  • K874361 — BIODYNAMICS MODEL BI-300 BODY COMPOSITION ANALYZER (March 16, 1988)
  • K873807 — AUTOTRANSFUSION APPARATUS (March 9, 1988)
  • K874034 — ADR-22 AUTOMATIC DIALYZER REPROCESSOR (October 23, 1987)
  • K870052 — INFUMIX MIXING CONTAINER (February 27, 1987)
  • K822715 — PLATELET CENTRIFUGE (September 30, 1982)
  • K822716 — UNIVERSAL CENTRIFUGE (September 30, 1982)
  • K822422 — BASIC CENTRIFUGE (September 2, 1982)

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