FDA 510(k)

Autoclave Indicator Tape; EO Indicator Tape

Numéro K : K241036 · 2024-12-17

DemandeurJiangmen New Era External Use Drug Co., Ltd.

Date de décision2024-12-17

Code produitJOJ

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Autoclave Indicator Tape; EO Indicator Tape is the device name listed in this FDA 510(k) record. The listed applicant is Jiangmen New Era External Use Drug Co., Ltd.. It received FDA 510(k) clearance on 2024-12-17 under 510(k) number K241036. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Autoclave Indicator Tape; EO Indicator Tape?

Autoclave Indicator Tape; EO Indicator Tape is a medical device that received FDA 510(k) clearance on 2024-12-17. The listed applicant is Jiangmen New Era External Use Drug Co., Ltd.. The 510(k) number is K241036.

When did Autoclave Indicator Tape; EO Indicator Tape receive FDA 510(k) clearance?

Autoclave Indicator Tape; EO Indicator Tape received FDA 510(k) clearance on 2024-12-17, under 510(k) number K241036.

Who is the listed applicant for Autoclave Indicator Tape; EO Indicator Tape?

The FDA 510(k) record lists Jiangmen New Era External Use Drug Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Autoclave Indicator Tape; EO Indicator Tape?

The FDA product code for Autoclave Indicator Tape; EO Indicator Tape is JOJ.

Essais cliniques associés

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Dispositifs connexes (Code : JOJ)

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Source officielle

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