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510(k) K990642

ECHOFLOW DOPPLER BLOOD VELOCITY METER by Echocath, Inc. — Product Code JOP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1999
Date Received
February 26, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic
Device Class
Class II
Regulation Number
870.2880
Review Panel
CV
Submission Type

Other clearances by Echocath, Inc.

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  • K932436 — ECHOMARK INTRAUTERINE GUIDING CATHETER (November 16, 1995)
  • K933417 — ECHOMARK(R) ELECTROPHYSIOLOGY CATHETER (May 4, 1995)
  • K926351 — COLORMARK(TM) VISUALIZATION SYSTEM (September 16, 1993)
  • K922787 — ECHOMARK GUIDEWIRE WITH ULTRASONIC LOCALIZATION (January 6, 1993)

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  • K071730 — STUDIODOP VICORDER (December 20, 2007)
  • K010482 — ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1 (March 20, 2001)
  • K002766 — NICOLET VASOGUARD (November 30, 2000)
  • K925078 — SPECTRADOP (July 17, 1995)