EA STIMULATOR— 510(k) K080221

Substantially Equivalent

Helio Medical Supplies, Inc.

FDA 510(k) clearance K080221 for EA STIMULATOR, Substantially Equivalent on 2008-09-09. Applicant: Helio Medical Supplies, Inc.. Device class: 2.

Clearance details

Applicant
Helio Medical Supplies, Inc.
Product code
Code GZJ
Device class
Class 2
Regulation
21 CFR 882.5890
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Jose, CA, US
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