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510(k) K930440

MARCO INTERNATIONAL STAND by Marco Ophthalmic, Inc. — Product Code HMF

K930440 is an FDA 510(k) premarket notification submitted by Marco Ophthalmic, Inc. for the device "MARCO INTERNATIONAL STAND". The FDA issued a decision of Substantially Equivalent on July 6, 1993. The device falls under product code HMF (Stand, Instrument, Ac-Powered, Ophthalmic), a Class I device regulated under 21 CFR 886.1860. 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
Stand, Instrument, Ac-Powered, Ophthalmic
Device Class
Class I
Regulation Number
886.1860
Review Panel
OP
Submission Type

Other clearances by Marco Ophthalmic, Inc.

  • K943234 — MS-30 AUTOMATIC PERIMETER (July 27, 1994)
  • K930444 — MARCO STANDARD KERATOMETERS (August 9, 1993)
  • K930437 — MARCO STANDARD RADIUSGAUGES (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)
  • K930443 — MARCO CP-600 AUTO CHART PROJECTOR/CP-1 CHART PROJE (July 6, 1993)
  • K930447 — MARCO H AND TS-1 INSTRUMENT TABLES (July 6, 1993)

Other clearances for product code HMF

  • K935952 — ROTA SYSTEM 5000 (April 19, 1994)
  • K935945 — ROTA DATAMATE I (April 19, 1994)
  • K931839 — ROTA SYSTEM XL (November 22, 1993)
  • K924780 — BURTON OPHTHALMIC EXAM UNIT - MODEL 2201 (April 5, 1993)
  • K924771 — BURTON OPHTHALMIC STAND - MODEL XL3200 (April 5, 1993)
  • K913961 — OPHTHALMIC STAND (December 4, 1991)
  • K853358 — RELIANCE PENDULUM OPHTHALMIC DELIVERY SYSTEM (October 4, 1985)
  • K844362 — OPHTHALMIC CHAIR (December 11, 1984)
  • K844363 — OPHTHALMIC STAND (December 5, 1984)
  • K832073 — ELECTRIC INSTRUMENT TABLE (August 12, 1983)

FDA data resources