The following data is part of a premarket notification filed by Versamed Medical Systems Ltd. with the FDA for Modification To Ivent 101.
| Device ID | K092135 |
| 510k Number | K092135 |
| Device Name: | MODIFICATION TO IVENT 101 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | VERSAMED MEDICAL SYSTEMS LTD. PO BOX 7550 Madison, WI 53707 -7550 |
| Contact | Adrianne Lenz |
| Correspondent | Adrianne Lenz VERSAMED MEDICAL SYSTEMS LTD. PO BOX 7550 Madison, WI 53707 -7550 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-15 |
| Decision Date | 2009-11-23 |
| Summary: | summary |