FDA 510(k)

SIRIO H3

K-Number: K163643 · 2017-11-16

Decision Date2017-11-16

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SIRIO H3 is the device name listed in this FDA 510(k) record. The listed applicant is Masmec Spa. It received FDA 510(k) clearance on 2017-11-16 under 510(k) number K163643. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIRIO H3?

SIRIO H3 is a medical device that received FDA 510(k) clearance on 2017-11-16. The listed applicant is Masmec Spa. The 510(k) number is K163643.

When did SIRIO H3 receive FDA 510(k) clearance?

SIRIO H3 received FDA 510(k) clearance on 2017-11-16, under 510(k) number K163643.

Who is the listed applicant for SIRIO H3?

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

What is the FDA product code for SIRIO H3?

The FDA product code for SIRIO H3 is JAK.

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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.