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FDA 510(k)

SCENAR, MODEL 10

K-Number: K092117 · 2010-05-28

ApplicantRitm Okb Zao
Decision Date2010-05-28
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SCENAR, MODEL 10 is the device name listed in this FDA 510(k) record. The listed applicant is Ritm Okb Zao. It received FDA 510(k) clearance on 2010-05-28 under 510(k) number K092117. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCENAR, MODEL 10?

SCENAR, MODEL 10 is a medical device that received FDA 510(k) clearance on 2010-05-28. The listed applicant is Ritm Okb Zao. The 510(k) number is K092117.

When did SCENAR, MODEL 10 receive FDA 510(k) clearance?

SCENAR, MODEL 10 received FDA 510(k) clearance on 2010-05-28, under 510(k) number K092117.

Who is the listed applicant for SCENAR, MODEL 10?

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

What is the FDA product code for SCENAR, MODEL 10?

The FDA product code for SCENAR, MODEL 10 is GZJ.

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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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