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510(k) K910049

INTERSPEC APOGEE, MODIFICATION by Interspec, Inc. — Product Code DPW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1991
Date Received
January 7, 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 Interspec, Inc.

  • K940671 — INTERSPEC APOGEE RX400 ULTRASOUND IMAGING SYSTEM AND DOPPLER ULTRASOUND FLOWMETE (November 22, 1994)
  • K924231 — INTERSPEC APOGEE CLA (June 14, 1993)
  • K915696 — INTERSPEC APOGEE ENDO-V PROBE AND NEEDLE GUIDE (November 24, 1992)
  • K920678 — ULTRASOUND IMAGAING SYSTEM AND DOPPLER FLOWMETER (April 2, 1992)
  • K911073 — PROBE REFILL KIT (June 6, 1991)
  • K903839 — INTERSPEC APOGEE (November 16, 1990)
  • K900155 — INTERSPEC 2 MHZ, TRANSCRANIAL PULSED WAVE DOPPLER (October 5, 1990)
  • K892944 — INTERSPEC TRANSESOPHAGEAL PROBE MODEL 4515 (July 19, 1989)
  • K890173 — INTERSPEC APOGEE (April 14, 1989)
  • K863372 — SM-20 CARDIOSCAN DOPPLER OPTION WITH CFM700 PROBES (November 4, 1986)

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