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FDA 510(k)

KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT

K-Number: K801418 · 1980-07-21

ApplicantKeeler Optical Products , Ltd.
Decision Date1980-07-21
Product CodeHPS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Keeler Optical Products , Ltd.. It received FDA 510(k) clearance on 1980-07-21 under 510(k) number K801418. The device is classified under product code HPS. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT?

KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT is a medical device that received FDA 510(k) clearance on 1980-07-21. The listed applicant is Keeler Optical Products , Ltd.. The 510(k) number is K801418.

When did KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT receive FDA 510(k) clearance?

KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT received FDA 510(k) clearance on 1980-07-21, under 510(k) number K801418.

Who is the listed applicant for KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT?

The FDA 510(k) record lists Keeler Optical Products , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT?

The FDA product code for KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT is HPS.

Related Clinical Trials

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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Other records listing Keeler Optical Products , Ltd. 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.

K810403KEELER/KONAN SPECULAR MICROSCOPEK792255NEVYAS AUTOPRESS EYE COMPRESSORK782141LEVIGATOR, KEELER PHOKOK781892LOCATOR, FOREIGN BODY

Related Devices (Code: HPS)

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.

K202038CryoTreQVitreQ BVK940373OPHTHALMIC CRYO UNITDutch Ophthalmic USA, Inc.K923629OPHTHALMIC TRICHIASIS PROBEMira, Inc.K903303SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBESSpembly Medical , Ltd.K874555KEELER ACU 22XT OPHTHALMIC CRYO UNITKeeler Instruments, Inc.K873388KEELER CTU CRYO SYSTEMKeeler Instruments, 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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