The following data is part of a premarket notification filed by Agamatrix Inc with the FDA for Jazz Wireless Blood Glucose Monitoring System, Model 8000-03381.
Device ID | K083265 |
510k Number | K083265 |
Device Name: | JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381 |
Classification | System, Test, Blood Glucose, Over The Counter |
Applicant | AGAMATRIX INC 10 MANOR PARKWAY Salem, NH 03079 |
Contact | Connie Hertel |
Correspondent | Connie Hertel AGAMATRIX INC 10 MANOR PARKWAY Salem, NH 03079 |
Product Code | NBW |
Subsequent Product Code | CGA |
Subsequent Product Code | JJX |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-11-05 |
Decision Date | 2009-02-03 |
Summary: | summary |