FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System
K Number: K220625
·
Decision Apr 6, 2022
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
65
Applicant Total
3
Review Days
34
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Basic Information
- Device Name
- ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System
- K Number
- K220625
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.5805
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Remed Co., Ltd.
- Date Received
- March 3, 2022
- Decision Date
- April 6, 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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