The following data is part of a premarket notification filed by Inovytech Medical Solutions Ltd. with the FDA for Ventway Sparrow.
| Device ID | K202970 |
| 510k Number | K202970 |
| Device Name: | Ventway Sparrow |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | Inovytech Medical Solutions Ltd. 3 Hanagar Street Hod Hasharon Tel-aviv, IL 4501306 |
| Contact | Dana Hofeller |
| Correspondent | Paul Dryden c/o ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, FL 33704 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-30 |
| Decision Date | 2021-01-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290017096902 | K202970 | 000 |
| 07290017096889 | K202970 | 000 |
| 17290017096770 | K202970 | 000 |
| 17290017096763 | K202970 | 000 |