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510(k) K896150

IMAGE 2000 SYSTEM, IMAGING, ULTRA-SONIC by Teknar, Inc. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 1990
Date Received
October 23, 1989
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)
  • 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)
  • K860757 — OPHTHASONIC A-SCAN (December 18, 1986)

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