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FDA 510(k)

MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPS

K-Number: K930442 · 1993-08-09

ApplicantMarco Ophthalmic, Inc.
Decision Date1993-08-09
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPS is the device name listed in this FDA 510(k) record. The listed applicant is Marco Ophthalmic, Inc.. It received FDA 510(k) clearance on 1993-08-09 under 510(k) number K930442. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPS?

MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPS is a medical device that received FDA 510(k) clearance on 1993-08-09. The listed applicant is Marco Ophthalmic, Inc.. The 510(k) number is K930442.

When did MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPS receive FDA 510(k) clearance?

MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPS received FDA 510(k) clearance on 1993-08-09, under 510(k) number K930442.

Who is the listed applicant for MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPS?

The FDA 510(k) record lists Marco Ophthalmic, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPS?

The FDA product code for MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPS is HKI.

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Other records listing Marco Ophthalmic, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K943234MS-30 AUTOMATIC PERIMETERK930444MARCO STANDARD KERATOMETERSK930438MARCO MODELS G,H AND PRIMARY CARE SLIT LAMPSK930437MARCO STANDARD RADIUSGAUGESK930439MARCO SURGISCOPE OPERATION MICROSCOPESK930447MARCO H AND TS-1 INSTRUMENT TABLES

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Related Devices (Code: HKI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253176TearViewBeyond 700 Pty, Ltd.K251353Eyer 2Phelcom TechnologiesK252120Fundus On Phone Non Mydriatic (FOP NM-10)Remidio Innovative Solutions Private LimitedK250770Optina-4C (MHRC-C1N)Optina Diagnostics, Inc.K2436003nethra neo HD FA; 3nethra neo HDForus Health Pvt.LtdK250683Resolve Fundus CameraOptain Health, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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