The following data is part of a premarket notification filed by Nova-ventrx with the FDA for Criterion, Criterion I.v., Modified.
| Device ID | K952267 |
| 510k Number | K952267 |
| Device Name: | CRITERION, CRITERION I.V., MODIFIED |
| Classification | Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer |
| Applicant | NOVA-VENTRX 1974 RAYMOND DR. Northbrook, IL 60062 |
| Contact | Bernard R Paluch |
| Correspondent | Bernard R Paluch NOVA-VENTRX 1974 RAYMOND DR. Northbrook, IL 60062 |
| Product Code | BZE |
| CFR Regulation Number | 868.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-15 |
| Decision Date | 1997-12-02 |