ACCU-CHEK SPIRIT
Pump, Infusion, Insulin
DISETRONIC MEDICAL SYSTEMS AG
The following data is part of a premarket notification filed by Disetronic Medical Systems Ag with the FDA for Accu-chek Spirit.
Pre-market Notification Details
| Device ID | K042887 |
| 510k Number | K042887 |
| Device Name: | ACCU-CHEK SPIRIT |
| Classification | Pump, Infusion, Insulin |
| Applicant | DISETRONIC MEDICAL SYSTEMS AG KIRCHBERGSTRASSE 190 Burgdorf, CH 3401 |
| Contact | Scott Thiel |
| Correspondent | Scott Thiel DISETRONIC MEDICAL SYSTEMS AG KIRCHBERGSTRASSE 190 Burgdorf, CH 3401 |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-19 |
| Decision Date | 2005-03-18 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04015630882908 | K042887 | 000 |
| 04015630882755 | K042887 | 000 |
Trademark Results [ACCU-CHEK SPIRIT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACCU-CHEK SPIRIT 79006404 3194287 Live/Registered |
Roche Diabetes Care GmbH 2004-08-27 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.