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510(k) K850116

BETASONIC III by Teknar, Inc. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1985
Date Received
January 14, 1985
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 Teknar, Inc.

  • K903666 — OPHTHASONIC A/P III (November 19, 1990)
  • K896038 — B-SCAN 10 MHZ PROBE (April 23, 1990)
  • K896150 — IMAGE 2000 SYSTEM, IMAGING, ULTRA-SONIC (January 18, 1990)
  • K891777 — PRO-CUT BIOPSY NEEDLE (May 4, 1989)
  • K883965 — PROBE, IMAGING, ULTRASONIC, MECHANICAL SECTOR (October 5, 1988)
  • K881850 — TEKNAR PERCU-SCAN (August 29, 1988)
  • K881605 — BIOPSY GUIDE (June 21, 1988)
  • K880659 — TEKNAR PROSCAN ACCESSORY PROBE (April 14, 1988)
  • K871536 — OPHTHASONIC A-SCAN/ B-SCAN (August 26, 1987)
  • K864807 — TEKNAR PROSCAN(TM) (July 10, 1987)

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