Glooko Mobile Insulin Dosing System
FDA 510(k) clearance K171450 · decided 2018-02-02
Clearance details
- K-number
- K171450
- Device name
- Glooko Mobile Insulin Dosing System
- Applicant
- Glooko, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-05-17
- Decision date
- 2018-02-02
- 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
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.