The following data is part of a premarket notification filed by Biovalve Technologies, Inc. with the FDA for Biovalve Insulin Delivery Systems (bids).
| Device ID | K050971 |
| 510k Number | K050971 |
| Device Name: | BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS) |
| Classification | Pump, Infusion, Insulin |
| Applicant | BIOVALVE TECHNOLOGIES, INC. 155 FLANDERS RD. Westborough, MA 01581 |
| Contact | Scott Huie |
| Correspondent | Scott Huie BIOVALVE TECHNOLOGIES, INC. 155 FLANDERS RD. Westborough, MA 01581 |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-18 |
| Decision Date | 2005-08-16 |
| Summary: | summary |