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510(k) K881968

BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER by Biodynamics Corp. — Product Code DSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1988
Date Received
May 11, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plethysmograph, Impedance
Device Class
Class II
Regulation Number
870.2770
Review Panel
CV
Submission Type

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  • 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)
  • K822716 — UNIVERSAL CENTRIFUGE (September 30, 1982)
  • K822715 — PLATELET CENTRIFUGE (September 30, 1982)
  • K822422 — BASIC CENTRIFUGE (September 2, 1982)

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