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FDA 510(k)

COLLIMATOR, MODEL M-38

K-Number: K062788 · 2006-12-28

ApplicantUmi International
Decision Date2006-12-28
Product CodeKPW
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

COLLIMATOR, MODEL M-38 is the device name listed in this FDA 510(k) record. The listed applicant is Umi International. It received FDA 510(k) clearance on 2006-12-28 under 510(k) number K062788. 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 COLLIMATOR, MODEL M-38?

COLLIMATOR, MODEL M-38 is a medical device that received FDA 510(k) clearance on 2006-12-28. The listed applicant is Umi International. The 510(k) number is K062788.

When did COLLIMATOR, MODEL M-38 receive FDA 510(k) clearance?

COLLIMATOR, MODEL M-38 received FDA 510(k) clearance on 2006-12-28, under 510(k) number K062788.

Who is the listed applicant for COLLIMATOR, MODEL M-38?

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

What is the FDA product code for COLLIMATOR, MODEL M-38?

The FDA product code for COLLIMATOR, MODEL M-38 is KPW.

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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.K030487R 72Ralco S.R.L.K954310BLA-800AToshiba Medical SystemsK946320R 302Ralco S.R.L.K914184P2020-8-0 BEAM-LIMITING DEVICEPrecise OpticsK904587DENSICOMP 250L. Keroack Co.

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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