510(k) clearance
BTL-699
- 510(k) number
- K260691
- Applicant
- BTL Industries, Inc.
- Decision date
- Aug 23, 2026
- Date received
- Mar 3, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- OBP
- Device type
- Transcranial Magnetic Stimulator
- Device class
- Class II
- Regulation
- 21 CFR 882.5805
- Advisory committee
- Neurology
- Statement or summary
- Summary
- Third party
- N
- Location
- Marlborough, MA, US