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510(k) K930449

MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIR by Marco Ophthalmic, Inc. — Product Code HME

K930449 is an FDA 510(k) premarket notification submitted by Marco Ophthalmic, Inc. for the device "MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIR". The FDA issued a decision of Substantially Equivalent on July 6, 1993. The device falls under product code HME (Chair, Ophthalmic, Ac-Powered), a Class I device regulated under 21 CFR 886.1140. 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
Chair, Ophthalmic, Ac-Powered
Device Class
Class I
Regulation Number
886.1140
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)
  • K930447 — MARCO H AND TS-1 INSTRUMENT TABLES (July 6, 1993)
  • K930446 — MARCO TRIAL SETS (July 6, 1993)
  • K930440 — MARCO INTERNATIONAL STAND (July 6, 1993)
  • K930443 — MARCO CP-600 AUTO CHART PROJECTOR/CP-1 CHART PROJE (July 6, 1993)

Other clearances for product code HME

  • K914416 — BREATH-EASY, MODIFICATION (June 23, 1992)
  • K894018 — RELIANCE(R) 6200 EXAMINATION CHAIR (September 12, 1989)
  • K870112 — STORZ ENT/OPHTHALMIC MAXI CHAIR (February 12, 1987)
  • K864574 — MAC 150E OPTHALMIC CHAIR (December 15, 1986)
  • K864494 — MODEL 6500 OPTHALMIC CHAIR (December 15, 1986)
  • K863728 — THE ERGOSYSTEM CHAIR (October 31, 1986)
  • K863008 — -OM WEST 2000 GNATUS CHAIR (September 24, 1986)
  • K853743 — TECHNA VISION, INC. ELECTRIC CHAIR (October 17, 1985)
  • K853151 — RELIANCE 5000 (September 5, 1985)
  • K853150 — RELIANCE 6100 (September 5, 1985)

FDA data resources