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FDA 510(k)

AMER. MEDICAL OPTICS DIGITAL KERATO-

K-Number: K842504 · 1984-10-01

ApplicantAmerican Medical Optics
Decision Date1984-10-01
Product CodeHQL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

AMER. MEDICAL OPTICS DIGITAL KERATO- 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 1984-10-01 under 510(k) number K842504. The device is classified under product code HQL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMER. MEDICAL OPTICS DIGITAL KERATO-?

AMER. MEDICAL OPTICS DIGITAL KERATO- is a medical device that received FDA 510(k) clearance on 1984-10-01. The listed applicant is American Medical Optics. The 510(k) number is K842504.

When did AMER. MEDICAL OPTICS DIGITAL KERATO- receive FDA 510(k) clearance?

AMER. MEDICAL OPTICS DIGITAL KERATO- received FDA 510(k) clearance on 1984-10-01, under 510(k) number K842504.

Who is the listed applicant for AMER. MEDICAL OPTICS DIGITAL KERATO-?

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 AMER. MEDICAL OPTICS DIGITAL KERATO-?

The FDA product code for AMER. MEDICAL OPTICS DIGITAL KERATO- is HQL.

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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 SETK851264AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMASK851263AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOPK851262AMER. MEDICAL OPTICAL BINOCULAR INDIRECT OPHTHALMAK844150MEDICAL OPTICS PHACOEMULSIFICATION KITK843966ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS

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Related Devices (Code: HQL)

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.

K914311CHIROFLEX II LENS MICROSERT(TM)Chiron OphthalmicsK913626SOFTRANS INJECTORStaar Surgical Co.K842892NIDEK DIGITAL KERATOMETERNidek, Inc.K771933CILCO ANTERIOR CHAMBER LENSCalifornia Intraocular Lens

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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