FDA 510(k)

UltraFlo-R Push Button Blood Collection Set

Numéro K : K220458 · 2023-09-29

DemandeurInnovative Medical Technologies, Inc.

Date de décision2023-09-29

Code produitJKA

Comité consultatifCH

DécisionSubstantially Equivalent

Résumé du dispositif

UltraFlo-R Push Button Blood Collection Set is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Medical Technologies, Inc.. It received FDA 510(k) clearance on 2023-09-29 under 510(k) number K220458. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the UltraFlo-R Push Button Blood Collection Set?

UltraFlo-R Push Button Blood Collection Set is a medical device that received FDA 510(k) clearance on 2023-09-29. The listed applicant is Innovative Medical Technologies, Inc.. The 510(k) number is K220458.

When did UltraFlo-R Push Button Blood Collection Set receive FDA 510(k) clearance?

UltraFlo-R Push Button Blood Collection Set received FDA 510(k) clearance on 2023-09-29, under 510(k) number K220458.

Who is the listed applicant for UltraFlo-R Push Button Blood Collection Set?

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

What is the FDA product code for UltraFlo-R Push Button Blood Collection Set?

The FDA product code for UltraFlo-R Push Button Blood Collection Set is JKA.

Essais cliniques associés

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Dispositifs connexes (Code : JKA)

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Source officielle

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