Home / 510(k) Clearances / K930443

510(k) K930443

MARCO CP-600 AUTO CHART PROJECTOR/CP-1 CHART PROJE by Marco Ophthalmic, Inc. — Product Code HOS

K930443 is an FDA 510(k) premarket notification submitted by Marco Ophthalmic, Inc. for the device "MARCO CP-600 AUTO CHART PROJECTOR/CP-1 CHART PROJE". The FDA issued a decision of Substantially Equivalent on July 6, 1993. The device falls under product code HOS (Projector, Ophthalmic), a Class I device regulated under 21 CFR 886.1680. Marco Ophthalmic, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 1993
Date Received
January 26, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Projector, Ophthalmic
Device Class
Class I
Regulation Number
886.1680
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)
  • K930441 — MARCO STANDARD LENSMETERS 101,201 (July 6, 1993)
  • K930446 — MARCO TRIAL SETS (July 6, 1993)
  • K930440 — MARCO INTERNATIONAL STAND (July 6, 1993)
  • K930447 — MARCO H AND TS-1 INSTRUMENT TABLES (July 6, 1993)

Other clearances for product code HOS

  • K936200 — WIRELESS CHART PROJECTOR,HCP-W 721 (September 28, 1994)
  • K924784 — BURTON PROJECTOR HEAD - MODEL 6000-H (April 5, 1993)
  • K921214 — OPHTHALMIC PROJECTOR (June 11, 1992)
  • K890992 — WOODLYN OPHTHALMIC PROJECTOR (May 17, 1989)
  • K862519 — BAUSCH & LOMB ACCU-CHART 3 ACUITY PROJECTOR (July 23, 1986)
  • K812706 — MILLER/NADLER GLARE TESTER (November 16, 1981)
  • K811180 — ULTRAMATIC PROJECT-O-CHART OPHTH. PROJ (May 15, 1981)
  • K781658 — PROJECTOR, ACCU-CHART ACUITY (October 17, 1978)

FDA data resources