The following data is part of a premarket notification filed by Cardiopulmonary Corp. with the FDA for Bernoulli Ventilator Management System.
| Device ID | K011861 |
| 510k Number | K011861 |
| Device Name: | BERNOULLI VENTILATOR MANAGEMENT SYSTEM |
| Classification | Accessory To Continuous Ventilator (respirator) |
| Applicant | CARDIOPULMONARY CORP. 200 CASCADE BLVD. Milford, CT 06460 |
| Contact | John Laviola |
| Correspondent | John Laviola CARDIOPULMONARY CORP. 200 CASCADE BLVD. Milford, CT 06460 |
| Product Code | MOD |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-14 |
| Decision Date | 2001-11-06 |