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510(k) K903666

OPHTHASONIC A/P III by Teknar, Inc. — Product Code HPY

K903666 is an FDA 510(k) premarket notification submitted by Teknar, Inc. for the device "OPHTHASONIC A/P III". The FDA issued a decision of Substantially Equivalent on November 19, 1990. The device falls under product code HPY (Unit, Electrolysis, Battery-Powered, Ophthalmic), a Class I device regulated under 21 CFR 886.4250. Teknar, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1990
Date Received
August 14, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrolysis, Battery-Powered, Ophthalmic
Device Class
Class I
Regulation Number
886.4250
Review Panel
OP
Submission Type

Other clearances by Teknar, Inc.

  • 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)
  • K860757 — OPHTHASONIC A-SCAN (December 18, 1986)

FDA data resources