The following data is part of a premarket notification filed by Versamed Ltd. with the FDA for Ivent 201 Portable Ventilator.
| Device ID | K021981 |
| 510k Number | K021981 |
| Device Name: | IVENT 201 PORTABLE VENTILATOR |
| Classification | Continuous, Ventilator, Home Use |
| Applicant | VERSAMED LTD. P.O.B. 5011, ORNAT BLDG. HASHRON INDUSTRIAL PARK Kadima, IL 60920 |
| Contact | Ken Raichman |
| Correspondent | Ken Raichman VERSAMED LTD. P.O.B. 5011, ORNAT BLDG. HASHRON INDUSTRIAL PARK Kadima, IL 60920 |
| Product Code | NOU |
| Subsequent Product Code | CBK |
| Subsequent Product Code | DQA |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-17 |
| Decision Date | 2003-08-13 |
| Summary: | summary |