FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Tempo Smart Button
K Number: K212217
·
Decision Sep 16, 2022
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
6
Applicant Total
5
Review Days
427
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Basic Information
- Device Name
- Tempo Smart Button
- K Number
- K212217
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Eli Lilly and Company
- Date Received
- July 16, 2021
- Decision Date
- September 16, 2022
- 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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