BTL-785BNF-E— 510(k) K242532
Substantially EquivalentBTL Industries, Inc.
FDA 510(k) clearance K242532 for BTL-785BNF-E, Substantially Equivalent on 2024-12-13. Applicant: BTL Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- BTL Industries, Inc.
- Product code
- Code NFO
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marlborough, MA, US
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