The following data is part of a premarket notification filed by Versamed Ltd. with the FDA for Smartvent 201 Portable Ventilator.
| Device ID | K981668 |
| 510k Number | K981668 |
| Device Name: | SMARTVENT 201 PORTABLE VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | VERSAMED LTD. 117 AHUZAH ST. Ra'ananna, IL 43373 |
| Contact | Shoshana Friedman |
| Correspondent | Shoshana Friedman VERSAMED LTD. 117 AHUZAH ST. Ra'ananna, IL 43373 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-11 |
| Decision Date | 1999-04-07 |
| Summary: | summary |