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FDA 510(k)

AMERICAN MEDICAL OPTICS I/A KIT- IRRIG

K-Number: K842197 · 1984-10-01

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

Device Summary

AMERICAN MEDICAL OPTICS I/A KIT- IRRIG 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 K842197. The device is classified under product code HQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERICAN MEDICAL OPTICS I/A KIT- IRRIG?

AMERICAN MEDICAL OPTICS I/A KIT- IRRIG 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 K842197.

When did AMERICAN MEDICAL OPTICS I/A KIT- IRRIG receive FDA 510(k) clearance?

AMERICAN MEDICAL OPTICS I/A KIT- IRRIG received FDA 510(k) clearance on 1984-10-01, under 510(k) number K842197.

Who is the listed applicant for AMERICAN MEDICAL OPTICS I/A KIT- IRRIG?

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 I/A KIT- IRRIG?

The FDA product code for AMERICAN MEDICAL OPTICS I/A KIT- IRRIG is HQE.

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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: HQE)

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.

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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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