FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
DEKA SIMON
K Number: K232334
·
Decision Sep 1, 2023
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
547
Applicant Total
15
Review Days
28
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Basic Information
- Device Name
- DEKA SIMON
- K Number
- K232334
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- El.En S.P.A.
- Date Received
- August 4, 2023
- Decision Date
- September 1, 2023
- Product Code
- IPF
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | FDA class 2 | Physical Medicine |
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| K234057 | NIRVANA | Apr 10, 2024 | Substantially Equivalent |
| K240537 | SMARTXIDE PRO | Mar 20, 2024 | Substantially Equivalent |
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