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FDA 510(k)

SOMNOLYZER 24X7

K-Number: K083620 · 2009-03-06

ApplicantThe Siesta Group North America
Decision Date2009-03-06
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SOMNOLYZER 24X7 is the device name listed in this FDA 510(k) record. The listed applicant is The Siesta Group North America. It received FDA 510(k) clearance on 2009-03-06 under 510(k) number K083620. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOMNOLYZER 24X7?

SOMNOLYZER 24X7 is a medical device that received FDA 510(k) clearance on 2009-03-06. The listed applicant is The Siesta Group North America. The 510(k) number is K083620.

When did SOMNOLYZER 24X7 receive FDA 510(k) clearance?

SOMNOLYZER 24X7 received FDA 510(k) clearance on 2009-03-06, under 510(k) number K083620.

Who is the listed applicant for SOMNOLYZER 24X7?

The FDA 510(k) record lists The Siesta Group North America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOMNOLYZER 24X7?

The FDA product code for SOMNOLYZER 24X7 is MNR.

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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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