Next Generation iBOT— 510(k) K172601

Name: FDA 510(k) clearance K172601
Creator: U.S. Food and Drug Administration
Published: 2018-03-02

Substantially Equivalent

Deka Research & Development Corp.

FDA 510(k) clearance K172601 for Next Generation iBOT, Substantially Equivalent on 2018-03-02. Applicant: Deka Research & Development Corp.. Device class: 2.

Clearance details

Applicant: Deka Research & Development Corp.
Product code: Code IMK
Device class: Class 2
Regulation: 21 CFR 890.3890
Advisory panel: Physical Medicine
Date received: 2017-08-30
Decision date: 2018-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Manchester, NH, US

Download summary PDF View on FDA.gov ↗

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