FDA 510(k)

Ingenuity TF

K-Number: K172406 · 2017-10-06

ApplicantPhilips Medical Systems (Cleveland), Inc.

Decision Date2017-10-06

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Ingenuity TF is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems (Cleveland), Inc.. It received FDA 510(k) clearance on 2017-10-06 under 510(k) number K172406. 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 Ingenuity TF?

Ingenuity TF is a medical device that received FDA 510(k) clearance on 2017-10-06. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K172406.

When did Ingenuity TF receive FDA 510(k) clearance?

Ingenuity TF received FDA 510(k) clearance on 2017-10-06, under 510(k) number K172406.

Who is the listed applicant for Ingenuity TF?

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

What is the FDA product code for Ingenuity TF?

The FDA product code for Ingenuity TF is KPS.

Other records listing Philips Medical Systems (Cleveland), Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.