The following data is part of a premarket notification filed by Nova-ventrx with the FDA for Modified Criterion Ventilator Breathing Circuit.
| Device ID | K863756 |
| 510k Number | K863756 |
| Device Name: | MODIFIED CRITERION VENTILATOR BREATHING CIRCUIT |
| Classification | Set, Tubing And Support, Ventilator (w Harness) |
| 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 | BZO |
| CFR Regulation Number | 868.5975 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-25 |
| Decision Date | 1986-11-13 |