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FDA 510(k)

DENSICOMP 250

K-Number: K904587 · 1991-01-24

ApplicantL. Keroack Co.
Decision Date1991-01-24
Product CodeKPW
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DENSICOMP 250 is the device name listed in this FDA 510(k) record. The listed applicant is L. Keroack Co.. It received FDA 510(k) clearance on 1991-01-24 under 510(k) number K904587. The device is classified under product code KPW. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENSICOMP 250?

DENSICOMP 250 is a medical device that received FDA 510(k) clearance on 1991-01-24. The listed applicant is L. Keroack Co.. The 510(k) number is K904587.

When did DENSICOMP 250 receive FDA 510(k) clearance?

DENSICOMP 250 received FDA 510(k) clearance on 1991-01-24, under 510(k) number K904587.

Who is the listed applicant for DENSICOMP 250?

The FDA 510(k) record lists L. Keroack Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DENSICOMP 250?

The FDA product code for DENSICOMP 250 is KPW.

Related Clinical Trials

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Related Devices (Code: KPW)

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.

K093596LUMOS, MODEL R 72BLumos, Inc.K062788COLLIMATOR, MODEL M-38Umi InternationalK030487R 72Ralco S.R.L.K954310BLA-800AToshiba Medical SystemsK946320R 302Ralco S.R.L.K914184P2020-8-0 BEAM-LIMITING DEVICEPrecise Optics

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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