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510(k) K930448

MARCO PROJECTION PERIMETER by Marco Ophthalmic, Inc. — Product Code HOO

K930448 is an FDA 510(k) premarket notification submitted by Marco Ophthalmic, Inc. for the device "MARCO PROJECTION PERIMETER". The FDA issued a decision of Substantially Equivalent on June 21, 1993. The device falls under product code HOO (Perimeter, Ac-Powered), a Class I device regulated under 21 CFR 886.1605. Marco Ophthalmic, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1993
Date Received
January 26, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Perimeter, Ac-Powered
Device Class
Class I
Regulation Number
886.1605
Review Panel
OP
Submission Type

Other clearances by Marco Ophthalmic, Inc.

  • K943234 — MS-30 AUTOMATIC PERIMETER (July 27, 1994)
  • K930437 — MARCO STANDARD RADIUSGAUGES (August 9, 1993)
  • K930444 — MARCO STANDARD KERATOMETERS (August 9, 1993)
  • K930438 — MARCO MODELS G,H AND PRIMARY CARE SLIT LAMPS (August 9, 1993)
  • K930442 — MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPS (August 9, 1993)
  • K930439 — MARCO SURGISCOPE OPERATION MICROSCOPES (July 22, 1993)
  • K930440 — MARCO INTERNATIONAL STAND (July 6, 1993)
  • K930446 — MARCO TRIAL SETS (July 6, 1993)
  • K930447 — MARCO H AND TS-1 INSTRUMENT TABLES (July 6, 1993)
  • K930441 — MARCO STANDARD LENSMETERS 101,201 (July 6, 1993)

Other clearances for product code HOO

  • K941723 — WELCH ALLYN GLAUCOMA DETECTOR (June 6, 1994)
  • K873912 — RICHMOND VISUAL FIELD SCREENER (November 2, 1987)
  • K864467 — HENSON - HAMBLIN CFS 2000 CENTRAL FIELD SCREEN (December 15, 1986)
  • K860115 — DIGILAB CAMBRIDGE PERIMETER (February 27, 1986)
  • K832800 — AUTOMATIC TANGENT SCREEN 50 (September 29, 1983)

FDA data resources