The following data is part of a premarket notification filed by Lifescan, Inc. with the FDA for Onetouch Ultramini Blood Glucose Monitoring System.
| Device ID | K061118 |
| 510k Number | K061118 |
| Device Name: | ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | LIFESCAN, INC. 1000 GIBRALTAR DR. Milpitas, CA 95035 -6312 |
| Contact | Mary Ellen Holden |
| Correspondent | Mary Ellen Holden 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 | 2006-04-21 |
| Decision Date | 2006-05-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20353885011468 | K061118 | 000 |
| 20353885008161 | K061118 | 000 |
| 20353885008130 | K061118 | 000 |
| 20353885002688 | K061118 | 000 |
| 20353885002671 | K061118 | 000 |
| 20353885001315 | K061118 | 000 |
| 20353885001285 | K061118 | 000 |
| 20353885000516 | K061118 | 000 |
| 20353885000486 | K061118 | 000 |