The following data is part of a premarket notification filed by Versamed Medical Systems Ltd. with the FDA for Ivent101.
| Device ID | K112754 |
| 510k Number | K112754 |
| Device Name: | IVENT101 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | VERSAMED MEDICAL SYSTEMS LTD. HASHARON INDUSTRIAL PARK ORNAT BLDG. P.O. BOX 5011 Kadima, IL 60920 |
| Contact | Shlomi Deler |
| Correspondent | Shlomi Deler VERSAMED MEDICAL SYSTEMS LTD. HASHARON INDUSTRIAL PARK ORNAT BLDG. P.O. BOX 5011 Kadima, IL 60920 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-21 |
| Decision Date | 2012-06-15 |
| Summary: | summary |