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510(k) K920333

SMARTDOP 20 BI-DIRECTIONAL BLOOD FLOW DETECTOR by Koven and Assoc., Inc. — Product Code DPW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1993
Date Received
January 27, 1992
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 Koven and Assoc., Inc.

  • K922669 — MULTIDOP MODEL HD-2020 BI-DIRECTIONAL BLOOD FLOW (January 29, 1993)
  • K915550 — MINI DOPPLER II ULTRASOUND BLOOD FLOW DETECTOR (December 10, 1992)
  • K913595 — DS-240 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM (March 27, 1992)
  • K912409 — MODEL HD-207 BIDIRECTIONAL VELOCITY METER (December 23, 1991)
  • 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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