The following data is part of a premarket notification filed by Nova-ventrx with the FDA for Res-q 1, 2, 3, 4 And 5.
| Device ID | K881207 |
| 510k Number | K881207 |
| Device Name: | RES-Q 1, 2, 3, 4 AND 5 |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | NOVA-VENTRX 4309 REGENCY DR. Wheeling, IL 60025 |
| Contact | Bernard R Paluch |
| Correspondent | Bernard R Paluch NOVA-VENTRX 4309 REGENCY DR. Wheeling, IL 60025 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-21 |
| Decision Date | 1988-08-15 |