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FDA 510(k)

KEELER CRYO MASTER & PROBES

K-Number: K992954 · 1999-12-21

ApplicantKeeler Instruments, Inc.
Decision Date1999-12-21
Product CodeHRN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KEELER CRYO MASTER & PROBES 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 1999-12-21 under 510(k) number K992954. The device is classified under product code HRN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KEELER CRYO MASTER & PROBES?

KEELER CRYO MASTER & PROBES is a medical device that received FDA 510(k) clearance on 1999-12-21. The listed applicant is Keeler Instruments, Inc.. The 510(k) number is K992954.

When did KEELER CRYO MASTER & PROBES receive FDA 510(k) clearance?

KEELER CRYO MASTER & PROBES received FDA 510(k) clearance on 1999-12-21, under 510(k) number K992954.

Who is the listed applicant for KEELER CRYO MASTER & PROBES?

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 KEELER CRYO MASTER & PROBES?

The FDA product code for KEELER CRYO MASTER & PROBES is HRN.

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Other records listing Keeler Instruments, Inc. 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.

K181143Keeler TonoCare TonometerK112093CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTERK093298PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000K100500PSL CLASSIC SLIT LAMPK062412CRYOMATICK060822VANTAGE INDIRECT OPHTHALMOSCOPE

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Related Devices (Code: HRN)

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.

K200911MIRA AdapterPhakosK180195Frigitronics adapterPhakosK162756PHAKOS Disposable Retinal Cryo ProbePhakosK160591D.O.R.C. Disposable Cryo ProbeDutch Ophthalmic Research Center International BVK131787CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBESKeeler, Ltd.K112093CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTERKeeler 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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