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FDA 510(k)

SOMATOM Drive

K-Number: K161196 · 2016-08-24

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2016-08-24
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SOMATOM Drive is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2016-08-24 under approval number K161196. 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 Drive?

SOMATOM Drive is a medical device that received FDA 510(k) clearance on 2016-08-24. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K161196.

When was SOMATOM Drive approved by the FDA?

SOMATOM Drive received FDA 510(k) clearance on 2016-08-24, under approval number K161196.

What company makes SOMATOM Drive?

SOMATOM Drive is manufactured by Siemens Medical Solutions USA, Inc..

What is the FDA product code for SOMATOM Drive?

The FDA product code for SOMATOM Drive is JAK.

Other Devices by Siemens Medical Solutions USA, Inc.

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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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