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FDA 510(k)

SOMATOM SMILE

K-Number: K003152 · 2000-10-24

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2000-10-24
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SOMATOM SMILE 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 2000-10-24 under 510(k) number K003152. 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 SOMATOM SMILE?

SOMATOM SMILE is a medical device that received FDA 510(k) clearance on 2000-10-24. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K003152.

When did SOMATOM SMILE receive FDA 510(k) clearance?

SOMATOM SMILE received FDA 510(k) clearance on 2000-10-24, under 510(k) number K003152.

Who is the listed applicant for SOMATOM SMILE?

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 SOMATOM SMILE?

The FDA product code for SOMATOM SMILE 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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