Home / 510(k) Clearances / K010482

510(k) K010482

ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1 by Echocath, Inc. — Product Code JOP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2001
Date Received
February 20, 2001
Clearance Type
Special
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.

  • K990642 — ECHOFLOW DOPPLER BLOOD VELOCITY METER (September 16, 1999)
  • 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)

Other clearances for product code JOP

  • K242662 — Falcon/Xpress (Falcon/Xpress) (December 18, 2024)
  • K233976 — VasoGuard (V10, V8, V6, V4, V2) (July 19, 2024)
  • K153762 — Smartdop XT6 (May 25, 2016)
  • K131623 — SMARTDOP XT (January 17, 2014)
  • K131860 — VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING (September 27, 2013)
  • K111416 — FALCON (July 15, 2011)
  • K071730 — STUDIODOP VICORDER (December 20, 2007)
  • K002766 — NICOLET VASOGUARD (November 30, 2000)
  • K990642 — ECHOFLOW DOPPLER BLOOD VELOCITY METER (September 16, 1999)
  • K925078 — SPECTRADOP (July 17, 1995)