The following data is part of a premarket notification filed by Artivent Corporation with the FDA for Save Resuscitator.
| Device ID | K073410 |
| 510k Number | K073410 |
| Device Name: | SAVE RESUSCITATOR |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | ARTIVENT CORPORATION 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Grace Holland |
| Correspondent | Grace Holland ARTIVENT CORPORATION 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-04 |
| Decision Date | 2008-09-12 |
| Summary: | summary |