FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BTL-995-rTMS
K Number: K212723
·
Decision Mar 4, 2022
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
65
Applicant Total
42
Review Days
189
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Basic Information
- Device Name
- BTL-995-rTMS
- K Number
- K212723
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5805
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BTL Industries, Inc.
- Date Received
- August 27, 2021
- Decision Date
- March 4, 2022
- Product Code
- OBP
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OBP | Transcranial Magnetic Stimulator | FDA class 2 | Neurology |
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Other Clearances by BTL Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252963 | BTL-899TT | Jun 12, 2026 | Substantially Equivalent |
| K253750 | BTL-785NEH | Mar 17, 2026 | Substantially Equivalent |
| K252561 | BTL-754FF | Feb 18, 2026 | Substantially Equivalent |
| K250309 | BTL-199 | Aug 7, 2025 | Substantially Equivalent |
| K243290 | BTL-785MJ | May 9, 2025 | Substantially Equivalent |
| K241516 | BTL-398 | Feb 10, 2025 | Substantially Equivalent |
| K241270 | BTL-754 | Jan 30, 2025 | Substantially Equivalent |
| K242532 | BTL-785BNF-E | Dec 13, 2024 | Substantially Equivalent |
| K240234 | BTL-899MS | Aug 17, 2024 | Substantially Equivalent |
| K233849 | BTL-499 | Apr 23, 2024 | Substantially Equivalent |