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510(k) K893035

OPHTHASCAN 'S' MINI-A by Biophysic Medical, Inc. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 1989
Date Received
April 24, 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 Biophysic Medical, Inc.

  • K953399 — NEEDLE OR CUTTER (October 30, 1995)
  • K890509 — INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEM (March 24, 1989)
  • K884595 — OPHTHASCAN MINI-B (January 3, 1989)
  • K884456 — STERILE DISPOSABLE ENDOCULAR PROBE (December 9, 1988)
  • K883719 — INTERCONN. OF OPHTHALAS & NANOLAS LASER SYSTEM (October 18, 1988)
  • K881494 — FOUR MODIFICATIONS TO OPHTHALAS ARGON/DYE LASER (August 30, 1988)
  • K881459 — NANOLAS ND:YAG OPHTHALMIC LASER (April 13, 1988)
  • K873460 — OPHTHALAS DYE OPHTHALMIC LASER (October 29, 1987)
  • K853116 — PAXIAL (October 31, 1985)
  • K844686 — OPHTHASCAN B (September 13, 1985)

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