The following data is part of a premarket notification filed by Integrated Sensing Systems, Inc. with the FDA for Issys Drug Flow Monitor.
| Device ID | K050783 |
| 510k Number | K050783 |
| Device Name: | ISSYS DRUG FLOW MONITOR |
| Classification | Monitor, Electric For Gravity Flow Infusion Systems |
| Applicant | INTEGRATED SENSING SYSTEMS, INC. 391 AIRPORT INDUSTRIAL DRIVE Ypsilanti, MI 48198 |
| Contact | Stephen Goldner, Jd, Rac |
| Correspondent | Stephen Goldner, Jd, Rac INTEGRATED SENSING SYSTEMS, INC. 391 AIRPORT INDUSTRIAL DRIVE Ypsilanti, MI 48198 |
| Product Code | FLN |
| CFR Regulation Number | 880.2420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-28 |
| Decision Date | 2006-02-22 |