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FDA 510(k)

SOMATOM SENSATION 64 AND SENSATION CARDIAC

K-Number: K040665 · 2004-04-02

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2004-04-02
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SOMATOM SENSATION 64 AND SENSATION CARDIAC 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 2004-04-02 under 510(k) number K040665. 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 SENSATION 64 AND SENSATION CARDIAC?

SOMATOM SENSATION 64 AND SENSATION CARDIAC is a medical device that received FDA 510(k) clearance on 2004-04-02. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K040665.

When did SOMATOM SENSATION 64 AND SENSATION CARDIAC receive FDA 510(k) clearance?

SOMATOM SENSATION 64 AND SENSATION CARDIAC received FDA 510(k) clearance on 2004-04-02, under 510(k) number K040665.

Who is the listed applicant for SOMATOM SENSATION 64 AND SENSATION CARDIAC?

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 SENSATION 64 AND SENSATION CARDIAC?

The FDA product code for SOMATOM SENSATION 64 AND SENSATION CARDIAC 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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