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510(k) K881979

RESUBMITTAL OF MI 1000C MICROIMAGER by Ausonics Pty , Ltd. — Product Code JOP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 1989
Date Received
May 12, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic
Device Class
Class II
Regulation Number
870.2880
Review Panel
CV
Submission Type

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  • K902728 — 7.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815) (February 13, 1991)
  • K896714 — AUSONICS 5000 (June 11, 1990)
  • 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)
  • K883372 — ALPHA MC-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT (November 25, 1988)

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