The following data is part of a premarket notification filed by Versamed Medical Systems, Inc. with the FDA for Ivent 2001 Mri Conditional.
| Device ID | K073694 |
| 510k Number | K073694 |
| Device Name: | IVENT 2001 MRI CONDITIONAL |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | VERSAMED MEDICAL SYSTEMS, INC. 3460 POINTE CREEK CT SUITE 102 Bonita Springs, FL 34134 -2015 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden VERSAMED MEDICAL SYSTEMS, INC. 3460 POINTE CREEK CT SUITE 102 Bonita Springs, FL 34134 -2015 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-31 |
| Decision Date | 2008-05-30 |
| Summary: | summary |