FDA 510(k)

BIOGRAPH 6 TRUEPOINT, MODEL BIOGRAPH 6 - P/N 10238197

K-Number: K071068 · 2007-05-14

ApplicantSiemens Medical Solutions USA, Inc.

Decision Date2007-05-14

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

BIOGRAPH 6 TRUEPOINT, MODEL BIOGRAPH 6 - P/N 10238197 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 2007-05-14 under 510(k) number K071068. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOGRAPH 6 TRUEPOINT, MODEL BIOGRAPH 6 - P/N 10238197?

BIOGRAPH 6 TRUEPOINT, MODEL BIOGRAPH 6 - P/N 10238197 is a medical device that received FDA 510(k) clearance on 2007-05-14. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K071068.

When did BIOGRAPH 6 TRUEPOINT, MODEL BIOGRAPH 6 - P/N 10238197 receive FDA 510(k) clearance?

BIOGRAPH 6 TRUEPOINT, MODEL BIOGRAPH 6 - P/N 10238197 received FDA 510(k) clearance on 2007-05-14, under 510(k) number K071068.

Who is the listed applicant for BIOGRAPH 6 TRUEPOINT, MODEL BIOGRAPH 6 - P/N 10238197?

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 BIOGRAPH 6 TRUEPOINT, MODEL BIOGRAPH 6 - P/N 10238197?

The FDA product code for BIOGRAPH 6 TRUEPOINT, MODEL BIOGRAPH 6 - P/N 10238197 is KPS.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.