The following data is part of a premarket notification filed by Hersill, S.l. with the FDA for Revivator.
| Device ID | K094003 |
| 510k Number | K094003 |
| Device Name: | REVIVATOR |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | HERSILL, S.L. PUERTO DE NAVACERRADA, 3 Mostoles ( Madrid), ES 28935 |
| Contact | Ana Maria Romero |
| Correspondent | Ana Maria Romero HERSILL, S.L. PUERTO DE NAVACERRADA, 3 Mostoles ( Madrid), ES 28935 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-28 |
| Decision Date | 2010-09-17 |
| Summary: | summary |