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510(k) K853432

5.0 IOP & 7.5 IOP PROBES by Diasonics, Inc. — Product Code GXW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1986
Date Received
August 15, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Echoencephalograph
Device Class
Class II
Regulation Number
882.1240
Review Panel
NE
Submission Type

Other clearances by Diasonics, Inc.

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  • 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)

Other clearances for product code GXW

  • K921863 — SONOS 500, 1000, 1500/SONOS OR ULTRASOUND IMAG SYS (September 28, 1992)
  • K903085 — SMS-712NA (October 5, 1990)
  • K833522 — NEURO SECTOR FIXATION DEVICE (May 25, 1984)
  • K821736 — ECHO-PULSE KM555 (December 9, 1982)
  • K770788 — ECHOENCEPHALOGRAPH, DIGITAL,DIGIECHO2000 (May 6, 1977)
  • K770575 — ECHOENCEPHALOGRAPH, DIGITAL, 1000 (April 26, 1977)