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510(k) K953716

INTRACAVITY TRANSDUCERS by Biosound, Inc. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 1996
Date Received
August 9, 1995
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 Biosound, Inc.

  • K971700 — BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCER (July 9, 1997)
  • K963936 — ACCESSPOINT, MED E-MAIL, DICOM READER (March 31, 1997)
  • K963262 — ARTOSCAN M (March 28, 1997)
  • K963662 — GALILEO EVOKED POTENTIALRE (February 26, 1997)
  • K953530 — DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A (April 8, 1996)
  • K953759 — DIAGNOSTIC ULTRASOUND TRANSDUCER (March 1, 1996)
  • K953819 — DIAGNOSTIC ULTRASOUND TRANDUCER (March 1, 1996)
  • K955458 — ULTRASOUND PROBE BIOPSY ACCESSORIES (February 12, 1996)
  • K953579 — TEE PROBE (February 2, 1996)
  • K953430 — ULTRASOUND PROBE BIOPSY ACCESSORIES (October 24, 1995)

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  • K231666 — Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) (December 13, 2023)
  • K231783 — VitroPRO (November 14, 2023)