Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SIRIO H3

K-Number: K163643 · 2017-11-16

ApplicantMasmec Spa
Decision Date2017-11-16
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SIRIO H3 is a medical device manufactured by Masmec Spa. It received FDA 510(k) clearance on 2017-11-16 under approval 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. It is manufactured by Masmec Spa. The 510(k) number is K163643.

When was SIRIO H3 approved by the FDA?

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

What company makes SIRIO H3?

SIRIO H3 is manufactured by Masmec Spa.

What is the FDA product code for SIRIO H3?

The FDA product code for SIRIO H3 is JAK.

Related Devices (Code: JAK)

K162302Somatom Confidence ® RT ProSiemens Medical Solutions USA, Inc. K163213Revolution CTGe Medical Systems, LLC K161157Vitrea CT Dual Energy Image ViewVital Images, Inc. K160723OnSight 3D Extremity SystemCarestream Health, Inc. K161196SOMATOM DriveSiemens Medical Solutions USA, Inc. K161748SUPRIA w/guideShot OptionHitachi Medical Systems America, Inc.

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.

↑