K-DEFIB/PACE CARBON ELECTRODE— 510(k) K926175
Substantially EquivalentKatecho, Inc.
FDA 510(k) clearance K926175 for K-DEFIB/PACE CARBON ELECTRODE, Substantially Equivalent on 1993-04-15. Applicant: Katecho, Inc.. Device class: 2.
Clearance details
- Applicant
- Katecho, Inc.
- Product code
- Code DRO
- Device class
- Class 2
- Regulation
- 21 CFR 870.5550
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Des Moines, IA, US
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More clearances from Katecho, Inc.
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