The following data is part of a premarket notification filed by Nova-ventrx with the FDA for Criterion I.v. Ventilator Breathing Circuit #1004.
| Device ID | K893760 |
| 510k Number | K893760 |
| Device Name: | CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004 |
| Classification | Set, Tubing And Support, Ventilator (w Harness) |
| 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 | BZO |
| CFR Regulation Number | 868.5975 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-19 |
| Decision Date | 1989-08-10 |