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510(k) K953530

DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A by Biosound, Inc. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1996
Date Received
July 27, 1995
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

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)
  • K953716 — INTRACAVITY TRANSDUCERS (April 17, 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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