510(k) clearance
Glucommander
- 510(k) number
- K261939
- Applicant
- Glytec, LLC
- Decision date
- Oct 5, 2026
- Date received
- Jun 10, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- NDC
- Device type
- Calculator, Drug Dose
- Device class
- Class II
- Regulation
- 21 CFR 868.1890
- Advisory committee
- Anesthesiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Greenville, SC, US