MODEL 45E HANDENGINE & CONTROLLER, MODEL 45EH HANDENGINE & CONTROLLER, MODEL RX-100 HANDENGINE & CONTROLLER, MODEL ETELN— 510(k) K964863
Substantially EquivalentBell Intl., Inc.
FDA 510(k) clearance K964863 for MODEL 45E HANDENGINE & CONTROLLER, MODEL 45EH HANDENGINE & CONTROLLER, MODEL RX-100 HANDENGINE & CONTROLLER, MODEL ETELN, Substantially Equivalent on 1997-02-28. Applicant: Bell Intl., Inc.. Device class: 1.
Clearance details
- Applicant
- Bell Intl., Inc.
- Product code
- Code EBW
- Device class
- Class 1
- Regulation
- 21 CFR 872.4200
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Burlingame, CA, US
Recent devices under product code EBW
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