BT-400— 510(k) K142332
Substantially EquivalentBio-Med USA
FDA 510(k) clearance K142332 for BT-400, Substantially Equivalent on 2015-03-20. Applicant: Bio-Med USA. Device class: 2.
Clearance details
- Applicant
- Bio-Med USA
- Product code
- Code LBI
- Device class
- Class 2
- Regulation
- 21 CFR 880.5700
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ramsey, NJ, US
Recent devices under product code LBI
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