510(k) K171822
K171822 is an FDA 510(k) premarket notification submitted by Biotest Medical Corporation for the device "NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352)". The FDA issued a decision of Substantially Equivalent on Sep 20, 2017. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Biotest Medical Corporation has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 20, 2017
- Date Received
- Jun 19, 2017
- Clearance Type
- Special
- 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)