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FDA 510(k)

SOMATOM Pro.Pulse

K-Number: K232206 · 2023-12-06

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2023-12-06
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SOMATOM Pro.Pulse is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2023-12-06 under approval number K232206. 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 Pro.Pulse?

SOMATOM Pro.Pulse is a medical device that received FDA 510(k) clearance on 2023-12-06. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K232206.

When was SOMATOM Pro.Pulse approved by the FDA?

SOMATOM Pro.Pulse received FDA 510(k) clearance on 2023-12-06, under approval number K232206.

What company makes SOMATOM Pro.Pulse?

SOMATOM Pro.Pulse is manufactured by Siemens Medical Solutions USA, Inc..

What is the FDA product code for SOMATOM Pro.Pulse?

The FDA product code for SOMATOM Pro.Pulse 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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