CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES— 510(k) K131787

Name: FDA 510(k) clearance K131787
Creator: U.S. Food and Drug Administration
Published: 2013-12-23

Substantially Equivalent

Keeler, Ltd.

FDA 510(k) clearance K131787 for CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES, Substantially Equivalent on 2013-12-23. Applicant: Keeler, Ltd.. Device class: 2.

Clearance details

Applicant: Keeler, Ltd.
Product code: Code HRN
Device class: Class 2
Regulation: 21 CFR 886.4170
Advisory panel: Ophthalmic
Date received: 2013-06-18
Decision date: 2013-12-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Broomall, PA, US

Download summary PDF View on FDA.gov ↗

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