ULTRATONE 8+ & 20— 510(k) K926410

Substantially Equivalent

Bowater Research, Inc.

FDA 510(k) clearance K926410 for ULTRATONE 8+ & 20, Substantially Equivalent on 1993-08-11. Applicant: Bowater Research, Inc.. Device class: 2.

Clearance details

Applicant: Bowater Research, Inc.
Product code: Code IPF
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 1992-12-21
Decision date: 1993-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fox Lake, IL, US

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