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510(k) K911073

PROBE REFILL KIT by Interspec, Inc. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1991
Date Received
March 11, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic, Diagnostic
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type

Other clearances by Interspec, Inc.

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  • K920678 — ULTRASOUND IMAGAING SYSTEM AND DOPPLER FLOWMETER (April 2, 1992)
  • K910049 — INTERSPEC APOGEE, MODIFICATION (April 29, 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)
  • K862913 — CARDIOSCAN WITH DOPPLER OPTION (November 4, 1986)

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