The following data is part of a premarket notification filed by Cardiopulmonary Corp. with the FDA for Bernoulli Management System, Oxinet Iii And Lifegard Vue.
| Device ID | K091461 |
| 510k Number | K091461 |
| Device Name: | BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE |
| Classification | Accessory To Continuous Ventilator (respirator) |
| 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 | MOD |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-18 |
| Decision Date | 2009-08-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854709006029 | K091461 | 000 |