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510(k) K834539

AXIPAC II by Teknar, Inc.

K834539 is an FDA 510(k) premarket notification submitted by Teknar, Inc. for the device "AXIPAC II". The FDA issued a decision of Substantially Equivalent on September 11, 1984. Teknar, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1984
Date Received
December 14, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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)

FDA data resources