The following data is part of a premarket notification filed by Cardiopulmonary Corp. with the FDA for Modification To Bernoulli Ventilator Management System Software.
| Device ID | K051283 |
| 510k Number | K051283 |
| Device Name: | MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE |
| Classification | System, Network And Communication, Physiological Monitors |
| Applicant | CARDIOPULMONARY CORP. 200 CASCADE BLVD. Milford, CT 06460 |
| Contact | Jordan Schreck |
| Correspondent | Jordan Schreck CARDIOPULMONARY CORP. 200 CASCADE BLVD. Milford, CT 06460 |
| Product Code | MSX |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-17 |
| Decision Date | 2005-06-23 |