The following data is part of a premarket notification filed by Cardiopulmonary Corp. with the FDA for Bernoulli Enterprise Software.
| Device ID | K130208 |
| 510k Number | K130208 |
| Device Name: | BERNOULLI ENTERPRISE SOFTWARE |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | CARDIOPULMONARY CORP. 200 CASCADE BLVD. Milford, CT 06460 |
| Contact | Urey Kang |
| Correspondent | Urey Kang CARDIOPULMONARY CORP. 200 CASCADE BLVD. Milford, CT 06460 |
| Product Code | MHX |
| Subsequent Product Code | MSX |
| Subsequent Product Code | PFY |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-28 |
| Decision Date | 2013-12-20 |