Go Dose System
FDA 510(k) clearance K160949 · decided 2016-12-22
Clearance details
- K-number
- K160949
- Device name
- Go Dose System
- Applicant
- Eli Lilly and Company
- Decision
- Substantially Equivalent
- Date received
- 2016-04-05
- Decision date
- 2016-12-22
- Days to decision
- 261 days
- Clearance type
- Traditional
- Product code
- NDC
- Device class
- 2
- Regulation number
- 868.1890
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.