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FDA 510(k)

SERIES 25 SLIMLINE CRYO PROBES

K-Number: K854422 · 1985-12-30

ApplicantKeeler Instruments, Inc.
Decision Date1985-12-30
Product CodeHQA
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SERIES 25 SLIMLINE CRYO 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 1985-12-30 under 510(k) number K854422. The device is classified under product code HQA. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERIES 25 SLIMLINE CRYO PROBES?

SERIES 25 SLIMLINE CRYO PROBES is a medical device that received FDA 510(k) clearance on 1985-12-30. The listed applicant is Keeler Instruments, Inc.. The 510(k) number is K854422.

When did SERIES 25 SLIMLINE CRYO PROBES receive FDA 510(k) clearance?

SERIES 25 SLIMLINE CRYO PROBES received FDA 510(k) clearance on 1985-12-30, under 510(k) number K854422.

Who is the listed applicant for SERIES 25 SLIMLINE CRYO 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 SERIES 25 SLIMLINE CRYO PROBES?

The FDA product code for SERIES 25 SLIMLINE CRYO PROBES is HQA.

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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: HQA)

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.

K854411KEELER-COMPACT CRYO SYSTEMKeeler Instruments, Inc.K841294ACU220 CRYO UNITKeller Instruments, Inc.K823835SPEMBLY 140 CRYOSYSTEM PROBES & TIPSKeller 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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