FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
BRAINSWAY DEEP TMS SYSTEM
K Number: K122288
·
Decision Jan 7, 2013
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
52
Applicant Total
1
Review Days
161
Basic Information
- Device Name
- BRAINSWAY DEEP TMS SYSTEM
- K Number
- K122288
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5805
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BRAINSWAY, LTD
- Date Received
- July 30, 2012
- Decision Date
- January 7, 2013
- 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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