VENTRAIN
Ventilator, Emergency, Powered (resuscitator)
DOLPHYS MEDICAL B.V.
The following data is part of a premarket notification filed by Dolphys Medical B.v. with the FDA for Ventrain.
Pre-market Notification Details
| Device ID | K132759 |
| 510k Number | K132759 |
| Device Name: | VENTRAIN |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | DOLPHYS MEDICAL B.V. DE LISMORTEL 31 Eindhoven, NL 5612ar |
| Contact | Fabienne Peters |
| Correspondent | Fabienne Peters DOLPHYS MEDICAL B.V. DE LISMORTEL 31 Eindhoven, NL 5612ar |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-04 |
| Decision Date | 2014-03-26 |
| Summary: | summary |
Trademark Results [VENTRAIN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VENTRAIN 79074210 3913206 Live/Registered |
Ventinova Technologies B.V. 2009-09-25 |
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