FDA 510(k)

Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102

K-번호: K162218 · 2016-11-22

결정일2016-11-22

제품 코드MLY

결정Substantially Equivalent

기기 요약

Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102 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 2016-11-22 under 510(k) number K162218. The device is classified under product code MLY. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102?

Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102 is a medical device that received FDA 510(k) clearance on 2016-11-22. The listed applicant is Nuance Medical, LLC. The 510(k) number is K162218.

When did Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102 receive FDA 510(k) clearance?

Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102 received FDA 510(k) clearance on 2016-11-22, under 510(k) number K162218.

Who is the listed applicant for Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102?

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 Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102?

The FDA product code for Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102 is MLY.

Nuance Medical, LLC를 신청인으로 등재한 기타 기록

K232674PainFreeze II K210310CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit K172203CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray K161337CryoDose H or Similar

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