The following data is part of a premarket notification filed by Lifescan, Inc. with the FDA for Symphony Meter Remote.
| Device ID | K082590 |
| 510k Number | K082590 |
| Device Name: | SYMPHONY METER REMOTE |
| Classification | Pump, Infusion, Insulin |
| Applicant | LIFESCAN, INC. 1000 GIBRALTAR DR. Milpitas, CA 95035 -6312 |
| Contact | Martha Murari |
| Correspondent | Martha Murari LIFESCAN, INC. 1000 GIBRALTAR DR. Milpitas, CA 95035 -6312 |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-08 |
| Decision Date | 2008-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20353885011673 | K082590 | 000 |
| 20353885010201 | K082590 | 000 |