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FDA 510(k)

DYNACT

K-Number: K042646 · 2004-10-19

ApplicantSiemens Medical Systems, Inc.
Decision Date2004-10-19
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DYNACT is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Systems, Inc.. It received FDA 510(k) clearance on 2004-10-19 under 510(k) number K042646. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYNACT?

DYNACT is a medical device that received FDA 510(k) clearance on 2004-10-19. The listed applicant is Siemens Medical Systems, Inc.. The 510(k) number is K042646.

When did DYNACT receive FDA 510(k) clearance?

DYNACT received FDA 510(k) clearance on 2004-10-19, under 510(k) number K042646.

Who is the listed applicant for DYNACT?

The FDA 510(k) record lists Siemens Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DYNACT?

The FDA product code for DYNACT is IZI.

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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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