The following data is part of a premarket notification filed by Cardiopulmonary Corp. with the FDA for Venturi Ventilator.
| Device ID | K982174 |
| 510k Number | K982174 |
| Device Name: | VENTURI VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | CARDIOPULMONARY CORP. 200 CASCADE BLVD. Milford, CT 06460 |
| Contact | James W Biondi |
| Correspondent | James W Biondi CARDIOPULMONARY CORP. 200 CASCADE BLVD. Milford, CT 06460 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-17 |
| Decision Date | 1998-06-24 |