OMNISOUND(TM) 3000— 510(k) K883893

Substantially Equivalent

Physio Technology, Inc.

FDA 510(k) clearance K883893 for OMNISOUND(TM) 3000, Substantially Equivalent on 1988-11-01. Applicant: Physio Technology, Inc.. Device class: 2.

Clearance details

Applicant
Physio Technology, Inc.
Product code
Code IMG
Device class
Class 2
Regulation
21 CFR 890.5860
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Topeka, KS, US
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