FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
SoloSmart Injection Pen Adapter (SoloSmart®)
K Number: K231820
·
Decision Jan 12, 2024
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
6
Applicant Total
4
Review Days
205
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Basic Information
- Device Name
- SoloSmart Injection Pen Adapter (SoloSmart®)
- K Number
- K231820
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biocorp Production
- Date Received
- June 21, 2023
- Decision Date
- January 12, 2024
- Product Code
- QOG
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| QOG | Injection Data Capture Device | FDA class 2 | General Hospital |
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