Cadwell Sierra Summit, Cadwell Sierra Ascent— 510(k) K162383

Name: FDA 510(k) clearance K162383
Creator: U.S. Food and Drug Administration
Published: 2017-03-01

Substantially Equivalent

Cadwell Industries, Inc.

FDA 510(k) clearance K162383 for Cadwell Sierra Summit, Cadwell Sierra Ascent, Substantially Equivalent on 2017-03-01. Applicant: Cadwell Industries, Inc.. Device class: 2.

Clearance details

Applicant: Cadwell Industries, Inc.
Product code: Code IKN
Device class: Class 2
Regulation: 21 CFR 890.1375
Advisory panel: Physical Medicine
Date received: 2016-08-25
Decision date: 2017-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kennewick, WA, US

Download summary PDF View on FDA.gov ↗

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