The following data is part of a premarket notification filed by Disetronic Medical Systems Ag with the FDA for Disetronic H-tronplus Insulin Infusion Pump.
| Device ID | K023471 |
| 510k Number | K023471 |
| Device Name: | DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP |
| Classification | Pump, Infusion, Insulin |
| Applicant | DISETRONIC MEDICAL SYSTEMS AG 5151 PROGRAM AVE. St. Paul, MN 55112 -1014 |
| Contact | David E Chadwick |
| Correspondent | David E Chadwick DISETRONIC MEDICAL SYSTEMS AG 5151 PROGRAM AVE. St. Paul, MN 55112 -1014 |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-15 |
| Decision Date | 2002-10-29 |
| Summary: | summary |