The following data is part of a premarket notification filed by Versamed Medical Systems, Inc. with the FDA for Ivent101.
| Device ID | K081845 |
| 510k Number | K081845 |
| Device Name: | IVENT101 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | VERSAMED MEDICAL SYSTEMS, INC. 2 BLUE HILL PLAZA BLDG. 2, 3RD FLOOR Pearl River, NY 10965 |
| Contact | Jerry Korten |
| Correspondent | Jerry Korten VERSAMED MEDICAL SYSTEMS, INC. 2 BLUE HILL PLAZA BLDG. 2, 3RD FLOOR Pearl River, NY 10965 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-30 |
| Decision Date | 2009-03-16 |
| Summary: | summary |