FDA 510(k)

ACU220 CRYO UNIT

K-Number: K841294 · 1984-08-15

Decision Date1984-08-15

Product CodeHQA

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

ACU220 CRYO UNIT 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 1984-08-15 under 510(k) number K841294. 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 ACU220 CRYO UNIT?

ACU220 CRYO UNIT is a medical device that received FDA 510(k) clearance on 1984-08-15. The listed applicant is Keller Instruments, Inc.. The 510(k) number is K841294.

When did ACU220 CRYO UNIT receive FDA 510(k) clearance?

ACU220 CRYO UNIT received FDA 510(k) clearance on 1984-08-15, under 510(k) number K841294.

Who is the listed applicant for ACU220 CRYO UNIT?

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 ACU220 CRYO UNIT?

The FDA product code for ACU220 CRYO UNIT is HQA.

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 FORCEPS K841292SPECTACLE INDIRECT OPHTHALMOSCOPE K841293PANORAMIC LOUPES - VARIOUS K823835SPEMBLY 140 CRYOSYSTEM PROBES & TIPS

Related Devices (Code: HQA)

K854422SERIES 25 SLIMLINE CRYO PROBESKeeler Instruments, Inc.K854411KEELER-COMPACT CRYO SYSTEMKeeler Instruments, Inc.K823835SPEMBLY 140 CRYOSYSTEM PROBES & TIPSKeller 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.