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510(k) K903984

CW DOPPLER/4.5 MHZ by Diasonics, Inc. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1991
Date Received
August 29, 1990
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 Diasonics, Inc.

  • K962662 — VINGMED SOUND COLOR FLOW MAPPING SYSTEM (January 2, 1997)
  • K924079 — CFM-800 COLOR FLOW MAPPING SYSTEM (September 28, 1993)
  • 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)
  • 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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