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FDA 510(k)

AMERICAN MEDICAL OPTICS PHOTOKERATO

K-Number: K842128 · 1984-08-07

ApplicantAmerican Medical Optics
Decision Date1984-08-07
Product CodeHJA
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

AMERICAN MEDICAL OPTICS PHOTOKERATO is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Optics. It received FDA 510(k) clearance on 1984-08-07 under 510(k) number K842128. The device is classified under product code HJA. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERICAN MEDICAL OPTICS PHOTOKERATO?

AMERICAN MEDICAL OPTICS PHOTOKERATO is a medical device that received FDA 510(k) clearance on 1984-08-07. The listed applicant is American Medical Optics. The 510(k) number is K842128.

When did AMERICAN MEDICAL OPTICS PHOTOKERATO receive FDA 510(k) clearance?

AMERICAN MEDICAL OPTICS PHOTOKERATO received FDA 510(k) clearance on 1984-08-07, under 510(k) number K842128.

Who is the listed applicant for AMERICAN MEDICAL OPTICS PHOTOKERATO?

The FDA 510(k) record lists American Medical Optics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMERICAN MEDICAL OPTICS PHOTOKERATO?

The FDA product code for AMERICAN MEDICAL OPTICS PHOTOKERATO is HJA.

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Other records listing American Medical Optics 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.

K860001BARRAQUER-KRUMEICH REFRACTIVE SETK851263AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOPK851264AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMASK851262AMER. MEDICAL OPTICAL BINOCULAR INDIRECT OPHTHALMAK844150MEDICAL OPTICS PHACOEMULSIFICATION KITK843966ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS

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Related Devices (Code: HJA)

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.

K901523VKG 1000, VIDEO KERATOGRAPHThe Sanborn Co.K893968VKG 2000 VIDEO KERATOMETERTechnitex, Inc.K830290DORC CONTACT/PHOTO DERATOSCOPEJedmed Instrument Co.K781650TERRY KERATOMETERClifford M. Terry, M.C.

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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