Heat Pain Pro— 510(k) K181992

Substantially Equivalent

Omron Healthcare, Inc.

FDA 510(k) clearance K181992 for Heat Pain Pro, Substantially Equivalent on 2018-11-09. Applicant: Omron Healthcare, Inc.. Device class: 2.

Clearance details

Applicant
Omron Healthcare, Inc.
Product code
Code NUH
Device class
Class 2
Regulation
21 CFR 882.5890
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Lake Forest, IL, US
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