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FDA 510(k)

CRYOPHTHALMIC UNIT

K-Number: K811244 · 1981-06-23

ApplicantKeeler Instruments, Inc.
Decision Date1981-06-23
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CRYOPHTHALMIC UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Keeler Instruments, Inc.. It received FDA 510(k) clearance on 1981-06-23 under 510(k) number K811244. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRYOPHTHALMIC UNIT?

CRYOPHTHALMIC UNIT is a medical device that received FDA 510(k) clearance on 1981-06-23. The listed applicant is Keeler Instruments, Inc.. The 510(k) number is K811244.

When did CRYOPHTHALMIC UNIT receive FDA 510(k) clearance?

CRYOPHTHALMIC UNIT received FDA 510(k) clearance on 1981-06-23, under 510(k) number K811244.

Who is the listed applicant for CRYOPHTHALMIC UNIT?

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

What is the FDA product code for CRYOPHTHALMIC UNIT?

The FDA product code for CRYOPHTHALMIC UNIT is HRS.

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Other records listing Keeler Instruments, Inc. as applicant

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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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