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FDA 510(k)

LUMOS, MODEL R 72B

K-Number: K093596 · 2010-01-12

ApplicantLumos, Inc.
Decision Date2010-01-12
Product CodeKPW
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LUMOS, MODEL R 72B is the device name listed in this FDA 510(k) record. The listed applicant is Lumos, Inc.. It received FDA 510(k) clearance on 2010-01-12 under 510(k) number K093596. 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 LUMOS, MODEL R 72B?

LUMOS, MODEL R 72B is a medical device that received FDA 510(k) clearance on 2010-01-12. The listed applicant is Lumos, Inc.. The 510(k) number is K093596.

When did LUMOS, MODEL R 72B receive FDA 510(k) clearance?

LUMOS, MODEL R 72B received FDA 510(k) clearance on 2010-01-12, under 510(k) number K093596.

Who is the listed applicant for LUMOS, MODEL R 72B?

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

What is the FDA product code for LUMOS, MODEL R 72B?

The FDA product code for LUMOS, MODEL R 72B is KPW.

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.

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.

Official Source

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