K242532
- 510(k) number
- K242532
- Device name
- BTL-785BNF-E
- Applicant
- BTL Industries, Inc. MA · US
- Product code
- NFO — Stimulator, Transcutaneous Electrical, Aesthetic Pur
- Decision date
- 2024-12-13
- Date received
- 2024-08-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K242532.pdf
Official FDA record: K242532
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.