Tempo Smart Button
FDA 510(k) clearance K212217 · decided 2022-09-16
Clearance details
- K-number
- K212217
- Device name
- Tempo Smart Button
- Applicant
- Eli Lilly and Company
- Decision
- Substantially Equivalent
- Date received
- 2021-07-16
- Decision date
- 2022-09-16
- Days to decision
- 427 days
- Clearance type
- Traditional
- Product code
- QOG
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Indianapolis, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.