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FDA 510(k)

CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES

K-Number: K131787 · 2013-12-23

ApplicantKeeler, Ltd.
Decision Date2013-12-23
Product CodeHRN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES is the device name listed in this FDA 510(k) record. The listed applicant is Keeler, Ltd.. It received FDA 510(k) clearance on 2013-12-23 under 510(k) number K131787. 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 MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES?

CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES is a medical device that received FDA 510(k) clearance on 2013-12-23. The listed applicant is Keeler, Ltd.. The 510(k) number is K131787.

When did CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES receive FDA 510(k) clearance?

CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES received FDA 510(k) clearance on 2013-12-23, under 510(k) number K131787.

Who is the listed applicant for CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES?

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

What is the FDA product code for CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES?

The FDA product code for CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES is HRN.

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, 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.

K131589KEELER SLIT LAMP H-SERIESK093445KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT)

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 BVK112093CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTERKeeler Instruments, Inc.K062412CRYOMATICKeeler Instruments, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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