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510(k) K933417

ECHOMARK(R) ELECTROPHYSIOLOGY CATHETER by Echocath, Inc. — Product Code DRF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 1995
Date Received
July 13, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class
Class II
Regulation Number
870.1220
Review Panel
CV
Submission Type

Other clearances by Echocath, Inc.

  • K010482 — ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1 (March 20, 2001)
  • K990642 — ECHOFLOW DOPPLER BLOOD VELOCITY METER (September 16, 1999)
  • K932436 — ECHOMARK INTRAUTERINE GUIDING CATHETER (November 16, 1995)
  • K926351 — COLORMARK(TM) VISUALIZATION SYSTEM (September 16, 1993)
  • K922787 — ECHOMARK GUIDEWIRE WITH ULTRASONIC LOCALIZATION (January 6, 1993)

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