FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Go Dose System
K Number: K160949
·
Decision Dec 22, 2016
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
54
Applicant Total
5
Review Days
261
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Basic Information
- Device Name
- Go Dose System
- K Number
- K160949
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1890
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Eli Lilly and Company
- Date Received
- April 5, 2016
- Decision Date
- December 22, 2016
- Product Code
- NDC
- Advisory Committee
- Anesthesiology
- 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 |
|---|---|---|---|
| NDC | Calculator, Drug Dose | FDA class 2 | Anesthesiology |
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