510(k) K101597
K101597 is an FDA 510(k) premarket notification submitted by Agamatrix for the device "WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4". The FDA issued a decision of Substantially Equivalent on October 18, 2010. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Agamatrix has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 18, 2010
- Date Received
- June 8, 2010
- 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