FDA 510(k)

JAS Pulse(TM) Ultrasonic Therapy

Número K: K161628 · 2016-11-10

Data da decisão2016-11-10

Código do produtoIMI

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

JAS Pulse(TM) Ultrasonic Therapy is the device name listed in this FDA 510(k) record. The listed applicant is Bonutti Research, Inc.. It received FDA 510(k) clearance on 2016-11-10 under 510(k) number K161628. The device is classified under product code IMI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the JAS Pulse(TM) Ultrasonic Therapy?

JAS Pulse(TM) Ultrasonic Therapy is a medical device that received FDA 510(k) clearance on 2016-11-10. The listed applicant is Bonutti Research, Inc.. The 510(k) number is K161628.

When did JAS Pulse(TM) Ultrasonic Therapy receive FDA 510(k) clearance?

JAS Pulse(TM) Ultrasonic Therapy received FDA 510(k) clearance on 2016-11-10, under 510(k) number K161628.

Who is the listed applicant for JAS Pulse(TM) Ultrasonic Therapy?

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

What is the FDA product code for JAS Pulse(TM) Ultrasonic Therapy?

The FDA product code for JAS Pulse(TM) Ultrasonic Therapy is IMI.

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