JAS Pulse(TM) Ultrasonic Therapy— 510(k) K161628

Name: FDA 510(k) clearance K161628
Creator: U.S. Food and Drug Administration
Published: 2016-11-10

Substantially Equivalent

Bonutti Research, Inc.

FDA 510(k) clearance K161628 for JAS Pulse(TM) Ultrasonic Therapy, Substantially Equivalent on 2016-11-10. Applicant: Bonutti Research, Inc.. Device class: 2.

Clearance details

Applicant: Bonutti Research, Inc.
Product code: Code IMI
Device class: Class 2
Regulation: 21 CFR 890.5300
Advisory panel: Physical Medicine
Date received: 2016-06-13
Decision date: 2016-11-10
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Effingham, IL, US

Download summary PDF View on FDA.gov ↗

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