The following data is part of a premarket notification filed by Event Medical Ltd with the FDA for Modification To Inspiration Ventilator System.
| Device ID | K030341 |
| 510k Number | K030341 |
| Device Name: | MODIFICATION TO INSPIRATION VENTILATOR SYSTEM |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | EVENT MEDICAL LTD 6A LIOSBAN BUSINESS PARK TUAM ROAD Galway, IE |
| Contact | Robbie Walsh |
| Correspondent | Robbie Walsh EVENT MEDICAL LTD 6A LIOSBAN BUSINESS PARK TUAM ROAD Galway, IE |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-03 |
| Decision Date | 2004-01-16 |
| Summary: | summary |