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510(k) K843971

AUSONICS 150 by Ausonics Pty , Ltd. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1985
Date Received
October 11, 1984
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

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  • K884299 — APA-C CATALOG NUMBER A-8001-C (January 10, 1989)
  • K883925 — UROIMAGER (December 15, 1988)
  • K883079 — WWDS-005 HUMAN RECTAL PROBE (December 14, 1988)

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