The following data is part of a premarket notification filed by Lifescan, Inc. with the FDA for Modification To One Touch Ultra Blood Glucose Monitoring System.
| Device ID | K062195 |
| 510k Number | K062195 |
| Device Name: | MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | LIFESCAN, INC. 1000 GIBRALTAR DR. Milpitas, CA 95035 -6312 |
| Contact | Cindy Morrow |
| Correspondent | Cindy Morrow 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 | 2006-08-01 |
| Decision Date | 2006-08-16 |
| Summary: | summary |