The following data is part of a premarket notification filed by Nova-ventrx with the FDA for Drv Disp Resuscit 3000/bag Adapt 3010 & 3011.
| Device ID | K870382 |
| 510k Number | K870382 |
| Device Name: | DRV DISP RESUSCIT 3000/BAG ADAPT 3010 & 3011 |
| Classification | Valve, Non-rebreathing |
| Applicant | NOVA-VENTRX 500 GLENN AVE. Wheeling, IL 60090 |
| Contact | Bernard R Paluch |
| Correspondent | Bernard R Paluch NOVA-VENTRX 500 GLENN AVE. Wheeling, IL 60090 |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-29 |
| Decision Date | 1987-03-06 |