KM-10 TENS ELECTRODE— 510(k) K000870
Substantially EquivalentKatecho, Inc.
FDA 510(k) clearance K000870 for KM-10 TENS ELECTRODE, Substantially Equivalent on 2000-11-07. Applicant: Katecho, Inc.. Device class: 2.
Clearance details
- Applicant
- Katecho, Inc.
- Product code
- Code GXY
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Des Moines, IA, US
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