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510(k) K912409

MODEL HD-207 BIDIRECTIONAL VELOCITY METER by Koven and Assoc., Inc. — Product Code JOP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1991
Date Received
May 31, 1991
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 Koven and Assoc., Inc.

  • K922669 — MULTIDOP MODEL HD-2020 BI-DIRECTIONAL BLOOD FLOW (January 29, 1993)
  • K920333 — SMARTDOP 20 BI-DIRECTIONAL BLOOD FLOW DETECTOR (January 22, 1993)
  • K915550 — MINI DOPPLER II ULTRASOUND BLOOD FLOW DETECTOR (December 10, 1992)
  • K913595 — DS-240 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM (March 27, 1992)
  • K903026 — ES-1000SP II SMART DOP (February 26, 1991)
  • K894892 — HD-2200 PNEUMO-DOP VASCULAR TESTING SYSTEM (October 27, 1989)
  • K892707 — DVM-4200 BLOOD FLOWMETER (July 28, 1989)

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  • 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)
  • K010482 — ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1 (March 20, 2001)
  • K002766 — NICOLET VASOGUARD (November 30, 2000)
  • K990642 — ECHOFLOW DOPPLER BLOOD VELOCITY METER (September 16, 1999)