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FDA 510(k)

SOMNOMED MAS RXA

K-Number: K050592 · 2005-07-12

ApplicantSomnomed, Ltd.
Decision Date2005-07-12
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SOMNOMED MAS RXA is the device name listed in this FDA 510(k) record. The listed applicant is Somnomed, Ltd.. It received FDA 510(k) clearance on 2005-07-12 under 510(k) number K050592. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOMNOMED MAS RXA?

SOMNOMED MAS RXA is a medical device that received FDA 510(k) clearance on 2005-07-12. The listed applicant is Somnomed, Ltd.. The 510(k) number is K050592.

When did SOMNOMED MAS RXA receive FDA 510(k) clearance?

SOMNOMED MAS RXA received FDA 510(k) clearance on 2005-07-12, under 510(k) number K050592.

Who is the listed applicant for SOMNOMED MAS RXA?

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

What is the FDA product code for SOMNOMED MAS RXA?

The FDA product code for SOMNOMED MAS RXA is LRK.

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Related Devices (Code: LRK)

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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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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