The following data is part of a premarket notification filed by Versamed Ltd. with the FDA for Ivent 201 Portable Ventilator.
| Device ID | K011957 |
| 510k Number | K011957 |
| Device Name: | IVENT 201 PORTABLE VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | VERSAMED LTD. ATIDIM INDUSTRIAL PARK, BLDG 2 P.O. BOX 58135 Tel-aviv, IL 61580 |
| Contact | Ken Raichman |
| Correspondent | Ken Raichman VERSAMED LTD. ATIDIM INDUSTRIAL PARK, BLDG 2 P.O. BOX 58135 Tel-aviv, IL 61580 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-22 |
| Decision Date | 2001-07-18 |
| Summary: | summary |