The following data is part of a premarket notification filed by Lifescan, Inc. with the FDA for Onetouch Zoom Diabetes Management Program.
| Device ID | K081318 |
| 510k Number | K081318 |
| Device Name: | ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | LIFESCAN, INC. 1000 GIBRALTAR DR. Milpitas, CA 95035 -6312 |
| Contact | Frank Peralta |
| Correspondent | Frank Peralta LIFESCAN, INC. 1000 GIBRALTAR DR. Milpitas, CA 95035 -6312 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-12 |
| Decision Date | 2008-06-09 |
| Summary: | summary |