FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Apollo TMS Therapy System
K Number: K232639
·
Decision May 24, 2024
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
65
Applicant Total
5
Review Days
268
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Basic Information
- Device Name
- Apollo TMS Therapy System
- K Number
- K232639
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5805
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mag & More GmbH
- Date Received
- August 30, 2023
- Decision Date
- May 24, 2024
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OBP), ordered by most recent decision date.
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BrainsWay Deep TMS System
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Other Clearances by Mag & More GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K260560 | Apollo TMS Therapy System;Apollo light TMS Therapy System | May 22, 2026 | Substantially Equivalent |
| K243700 | Apollo TMS Therapy System | Sep 4, 2025 | Substantially Equivalent |
| K243539 | Apollo TMS Therapy System | Aug 18, 2025 | Substantially Equivalent |
| K180313 | Apollo TMS Therapy System | May 4, 2018 | Substantially Equivalent |