The following data is part of a premarket notification filed by Hypoguard Usa, Inc. with the FDA for Glucobalance Data Management Software, Model 555020.
| Device ID | K022545 |
| 510k Number | K022545 |
| Device Name: | GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020 |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | HYPOGUARD USA, INC. 5182 WEST 76TH ST. Minneapolis, MN 55439 |
| Contact | Bruce A Macfarlane |
| Correspondent | Bruce A Macfarlane HYPOGUARD USA, INC. 5182 WEST 76TH ST. Minneapolis, MN 55439 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-01 |
| Decision Date | 2002-10-11 |
| Summary: | summary |