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510(k) K944485

4000 AU ULTRASOUND IMAGING SYSTEM by Biosound, Inc. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 1995
Date Received
September 13, 1994
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)
  • K953530 — DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A (April 8, 1996)
  • K953819 — DIAGNOSTIC ULTRASOUND TRANDUCER (March 1, 1996)
  • K953759 — DIAGNOSTIC ULTRASOUND TRANSDUCER (March 1, 1996)
  • K955458 — ULTRASOUND PROBE BIOPSY ACCESSORIES (February 12, 1996)
  • K953579 — TEE PROBE (February 2, 1996)

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