The following data is part of a premarket notification filed by Asante Solutions, Inc. with the FDA for Pearl Diabetes Management System.
| Device ID | K122483 |
| 510k Number | K122483 |
| Device Name: | PEARL DIABETES MANAGEMENT SYSTEM |
| Classification | Pump, Infusion, Insulin |
| Applicant | Asante Solutions, Inc. 352 E Java Dr Sunnyvale, CA 94089 |
| Contact | Robin Bush |
| Correspondent | Robin Bush Asante Solutions, Inc. 352 E Java Dr Sunnyvale, CA 94089 |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-14 |
| Decision Date | 2013-01-03 |
| Summary: | summary |