FDA 510(k)

Gown chirurgical AERO CHROME* respirant Select, Gown chirurgical AERO CHROME* A-Line respirant

Numéro K : K210688 · 2021-07-21

Date de décision2021-07-21

Code produitFYA

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown is the device name listed in this FDA 510(k) record. The listed applicant is O&M Halyard, Inc.. It received FDA 510(k) clearance on 2021-07-21 under 510(k) number K210688. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown?

AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown is a medical device that received FDA 510(k) clearance on 2021-07-21. The listed applicant is O&M Halyard, Inc.. The 510(k) number is K210688.

When did AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown receive FDA 510(k) clearance?

AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown received FDA 510(k) clearance on 2021-07-21, under 510(k) number K210688.

Who is the listed applicant for AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown?

The FDA 510(k) record lists O&M Halyard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown?

The FDA product code for AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown is FYA.

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Source officielle

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