The following data is part of a premarket notification filed by Tecme S.a. with the FDA for Neumovent Graphnet Model 3179l1v.
| Device ID | K101401 |
| 510k Number | K101401 |
| Device Name: | NEUMOVENT GRAPHNET MODEL 3179L1V |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | TECME S.A. 56B SHADOWBROOK DRIVE Hudson, NH 03051 |
| Contact | Raymond Kelly |
| Correspondent | Raymond Kelly TECME S.A. 56B SHADOWBROOK DRIVE Hudson, NH 03051 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-18 |
| Decision Date | 2010-12-07 |
| Summary: | summary |