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510(k) K912562

ABCOM 2000 by Applied Biometrics, Inc. — Product Code DPW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1992
Date Received
June 11, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flowmeter, Blood, Cardiovascular
Device Class
Class II
Regulation Number
870.2100
Review Panel
CV
Submission Type

Other clearances by Applied Biometrics, Inc.

  • K911320 — EXTRAVASCULAR DOPPLER (EVD) ULTRA BLOOD FLOW PROBE (December 18, 1991)
  • K870857 — ABCOM 1 CARDIAC OUTPUT MONITOR (November 16, 1987)

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