510(k) K151658
K151658 is an FDA 510(k) premarket notification submitted by Philosys, Inc. for the device "Gmate Origin Blood Glucose Monitoring System". The FDA issued a decision of Substantially Equivalent on Dec 1, 2015. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Philosys, Inc. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 1, 2015
- Date Received
- Jun 19, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Blood Glucose, Over The Counter
- Device Class
- Class II
- Regulation Number
- 862.1345
- Review Panel
- CH
- Submission Type
- 510(k)