FDA 510(k)

CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray

Número K: K172203 · 2017-10-18

Data da decisão2017-10-18

Código do produtoMLY

DecisãoSubstantially Equivalent

Resumo do dispositivo

CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray is the device name listed in this FDA 510(k) record. The listed applicant is Nuance Medical, LLC. It received FDA 510(k) clearance on 2017-10-18 under 510(k) number K172203. The device is classified under product code MLY. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray?

CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray is a medical device that received FDA 510(k) clearance on 2017-10-18. The listed applicant is Nuance Medical, LLC. The 510(k) number is K172203.

When did CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray receive FDA 510(k) clearance?

CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray received FDA 510(k) clearance on 2017-10-18, under 510(k) number K172203.

Who is the listed applicant for CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray?

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

What is the FDA product code for CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray?

The FDA product code for CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray is MLY.

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Outros registros que listam Nuance Medical, LLC como candidato(a)

K232674PainFreeze II K210310CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit K162218Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102 K161337CryoDose H or Similar

Dispositivos Relacionados (Código: MLY)

K261684FreezeSpray TACryosurgery, Inc.K260870Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)Gebauer Company K243654DentalJectVapocoolshot, Inc.K232674PainFreeze IINuance Medical, LLC K203661CRYO Arctic, CRYO PenguinCryoscience North America, Inc.K202782num Vapocoolant623 Medical, LLC

Fonte oficial

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