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510(k) K915550

MINI DOPPLER II ULTRASOUND BLOOD FLOW DETECTOR by Koven and Assoc., Inc. — Product Code DPW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1992
Date Received
December 11, 1991
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)
  • K920333 — SMARTDOP 20 BI-DIRECTIONAL BLOOD FLOW DETECTOR (January 22, 1993)
  • 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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