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FDA 510(k)

INNOVANCE Free PS Ag

K-Number: K181525 · 2018-09-07

ApplicantSiemens Healthcare Diagnostics Products GmbH
Decision Date2018-09-07
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

INNOVANCE Free PS Ag is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. It received FDA 510(k) clearance on 2018-09-07 under 510(k) number K181525. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INNOVANCE Free PS Ag?

INNOVANCE Free PS Ag is a medical device that received FDA 510(k) clearance on 2018-09-07. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. The 510(k) number is K181525.

When did INNOVANCE Free PS Ag receive FDA 510(k) clearance?

INNOVANCE Free PS Ag received FDA 510(k) clearance on 2018-09-07, under 510(k) number K181525.

Who is the listed applicant for INNOVANCE Free PS Ag?

The FDA 510(k) record lists Siemens Healthcare Diagnostics Products GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INNOVANCE Free PS Ag?

The FDA product code for INNOVANCE Free PS Ag is GGP.

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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.

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