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510(k) K903839

INTERSPEC APOGEE by Interspec, Inc. — Product Code DXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1990
Date Received
August 21, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Echocardiograph
Device Class
Class II
Regulation Number
870.2330
Review Panel
CV
Submission Type

Other clearances by Interspec, Inc.

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  • 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)
  • K910049 — INTERSPEC APOGEE, MODIFICATION (April 29, 1991)
  • 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)
  • K862913 — CARDIOSCAN WITH DOPPLER OPTION (November 4, 1986)

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