FDA 510(k)

TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support

Numéro K : K231168 · 2023-05-22

Date de décision2023-05-22

Code produitQJP

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support is the device name listed in this FDA 510(k) record. The listed applicant is Imperative Care, Inc.. It received FDA 510(k) clearance on 2023-05-22 under 510(k) number K231168. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support?

TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support is a medical device that received FDA 510(k) clearance on 2023-05-22. The listed applicant is Imperative Care, Inc.. The 510(k) number is K231168.

When did TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support receive FDA 510(k) clearance?

TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support received FDA 510(k) clearance on 2023-05-22, under 510(k) number K231168.

Who is the listed applicant for TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support?

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

What is the FDA product code for TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support?

The FDA product code for TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support is QJP.

Essais cliniques associés

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Source officielle

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