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510(k) K924079

CFM-800 COLOR FLOW MAPPING SYSTEM by Diasonics, Inc. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1993
Date Received
August 13, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

Other clearances by Diasonics, Inc.

  • K962662 — VINGMED SOUND COLOR FLOW MAPPING SYSTEM (January 2, 1997)
  • K911435 — CPA/3.5 MHZ PROBE (September 11, 1992)
  • K905200 — SACA, 3.5 MHZ PROBE (April 2, 1992)
  • K903562 — CW DOPPLER 2.25 MHZ PROBE (March 2, 1992)
  • K903984 — CW DOPPLER/4.5 MHZ (June 14, 1991)
  • K896637 — ACCESS(TM), SOFTWARE RELEASE 4.11P (January 22, 1990)
  • K893518 — MT/S SOFTWARE RELEASE 5.0. (October 27, 1989)
  • K894290 — ACCESS TM (September 7, 1989)
  • K893881 — ACCESS TM (June 23, 1989)
  • K891452 — SPECTRA ULTRASOUND SYSTEM W/COLOR FLOW MODULE (June 7, 1989)

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