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FDA 510(k)

CRYOMATIC

K-Number: K062412 · 2006-11-06

ApplicantKeeler Instruments, Inc.
Decision Date2006-11-06
Product CodeHRN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CRYOMATIC 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 2006-11-06 under 510(k) number K062412. 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 CRYOMATIC?

CRYOMATIC is a medical device that received FDA 510(k) clearance on 2006-11-06. The listed applicant is Keeler Instruments, Inc.. The 510(k) number is K062412.

When did CRYOMATIC receive FDA 510(k) clearance?

CRYOMATIC received FDA 510(k) clearance on 2006-11-06, under 510(k) number K062412.

Who is the listed applicant for CRYOMATIC?

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 CRYOMATIC?

The FDA product code for CRYOMATIC 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 LAMPK060822VANTAGE INDIRECT OPHTHALMOSCOPEK032087KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004

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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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