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 |