The following data is part of a premarket notification filed by Vedi Corp. with the FDA for Vadi Manual Resuscitator.
| Device ID | K030864 |
| 510k Number | K030864 |
| Device Name: | VADI MANUAL RESUSCITATOR |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | VEDI CORP. 6833 SAINT LAWRENCE ST. Plano, TX 75024 |
| Contact | Eric Luo |
| Correspondent | Eric Luo VEDI CORP. 6833 SAINT LAWRENCE ST. Plano, TX 75024 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-18 |
| Decision Date | 2004-01-30 |