EA STIMULATOR— 510(k) K080221
Substantially EquivalentHelio 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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