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 |