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FDA 510(k)

SPEMBLY 140 CRYOSYSTEM PROBES & TIPS

K-Number: K823835 · 1983-01-17

ApplicantKeller Instruments, Inc.
Decision Date1983-01-17
Product CodeHQA
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SPEMBLY 140 CRYOSYSTEM PROBES & TIPS is the device name listed in this FDA 510(k) record. The listed applicant is Keller Instruments, Inc.. It received FDA 510(k) clearance on 1983-01-17 under 510(k) number K823835. 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 SPEMBLY 140 CRYOSYSTEM PROBES & TIPS?

SPEMBLY 140 CRYOSYSTEM PROBES & TIPS is a medical device that received FDA 510(k) clearance on 1983-01-17. The listed applicant is Keller Instruments, Inc.. The 510(k) number is K823835.

When did SPEMBLY 140 CRYOSYSTEM PROBES & TIPS receive FDA 510(k) clearance?

SPEMBLY 140 CRYOSYSTEM PROBES & TIPS received FDA 510(k) clearance on 1983-01-17, under 510(k) number K823835.

Who is the listed applicant for SPEMBLY 140 CRYOSYSTEM PROBES & TIPS?

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

What is the FDA product code for SPEMBLY 140 CRYOSYSTEM PROBES & TIPS?

The FDA product code for SPEMBLY 140 CRYOSYSTEM PROBES & TIPS is HQA.

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 Keller 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.

K854541TIP OFF FORCEPSK841294ACU220 CRYO UNITK841292SPECTACLE INDIRECT OPHTHALMOSCOPEK841293PANORAMIC LOUPES - VARIOUS

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.

K854422SERIES 25 SLIMLINE CRYO PROBESKeeler Instruments, Inc.K854411KEELER-COMPACT CRYO SYSTEMKeeler Instruments, Inc.K841294ACU220 CRYO UNITKeller 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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