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510(k) K862627

SONORANGER TRANSVAGINAL PROBE by Ausonics Pty , Ltd. — Product Code HEM

Clearance Details

Decision
SN ()
Decision Date
August 1, 1986
Date Received
July 10, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Imager, Ultrasonic Obstetric-Gynecologic
Device Class
Class II
Regulation Number
884.2225
Review Panel
OB
Submission Type

Other clearances by Ausonics Pty , Ltd.

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  • K920307 — AUSONICS OPUS 1 SYSTEM, ANNULAR ARRAY OPTION (May 19, 1992)
  • K905488 — DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN (December 18, 1991)
  • K902728 — 7.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815) (February 13, 1991)
  • K896714 — AUSONICS 5000 (June 11, 1990)
  • K881979 — RESUBMITTAL OF MI 1000C MICROIMAGER (June 12, 1989)
  • 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)

Other clearances for product code HEM

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  • K905000 — ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER (January 31, 1991)
  • K900505 — SONOACE 88 PORTABLE ULTRASOUND SCANNER (August 10, 1990)
  • K900271 — MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK (April 19, 1990)
  • K890637 — EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE (June 12, 1989)
  • K881329 — FETAL DOPPLER FOR ULTRAMARK 4 AND 8 (April 14, 1989)
  • K885061 — SIEMENS INTRAVAGINAL TRANSDUCER (February 23, 1989)
  • K881185 — ANNULAR ARRAY PROBES FOR ARTIS 3200 DIAG. ULTRA. (June 1, 1988)