The following data is part of a premarket notification filed by Tecme S.a. with the FDA for Neumovent Graphnet.
| Device ID | K111595 |
| 510k Number | K111595 |
| Device Name: | NEUMOVENT GRAPHNET |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | TECME S.A. 79 BROOKLINE ROAD Mason, NH 03048 |
| Contact | Ray Kelly |
| Correspondent | Ray Kelly TECME S.A. 79 BROOKLINE ROAD Mason, NH 03048 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-07 |
| Decision Date | 2012-01-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07798148080109 | K111595 | 000 |
| 07798148080093 | K111595 | 000 |
| 07798148080086 | K111595 | 000 |