510(k) K171450
K171450 is an FDA 510(k) premarket notification submitted by Glooko, Inc. for the device "Glooko Mobile Insulin Dosing System". The FDA issued a decision of Substantially Equivalent on February 2, 2018. The device falls under product code NDC (Calculator, Drug Dose), a Class II device regulated under 21 CFR 868.1890. Glooko, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 2, 2018
- Date Received
- May 17, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calculator, Drug Dose
- Device Class
- Class II
- Regulation Number
- 868.1890
- Review Panel
- CH
- Submission Type