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FDA 510(k)

SAFIRE

K-Number: K103424 · 2011-11-22

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2011-11-22
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SAFIRE is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2011-11-22 under 510(k) number K103424. 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 SAFIRE?

SAFIRE is a medical device that received FDA 510(k) clearance on 2011-11-22. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K103424.

When did SAFIRE receive FDA 510(k) clearance?

SAFIRE received FDA 510(k) clearance on 2011-11-22, under 510(k) number K103424.

Who is the listed applicant for SAFIRE?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAFIRE?

The FDA product code for SAFIRE is JAK.

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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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