The following data is part of a premarket notification filed by Cilag Gmbh International with the FDA for Onetouch Verio Sync Blood Glucose Monitoring System.
| Device ID | K120708 |
| 510k Number | K120708 |
| Device Name: | ONETOUCH VERIO SYNC BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | CILAG GMBH INTERNATIONAL 1000 GIBRALTAR DRIVE Milpitas, CA 95035 |
| Contact | Nadine Nasr |
| Correspondent | Nadine Nasr CILAG GMBH INTERNATIONAL 1000 GIBRALTAR DRIVE Milpitas, CA 95035 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-08 |
| Decision Date | 2013-02-07 |
| Summary: | summary |