The following data is part of a premarket notification filed by Vortran Medical Technology 1, Inc. with the FDA for Vortran Go2vent With Peep Valve.
| Device ID | K202219 |
| 510k Number | K202219 |
| Device Name: | VORTRAN GO2VENT With PEEP Valve |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | Vortran Medical Technology 1, Inc. 21 Goldenland Court, Suite 100 Sacramento, CA 95834 |
| Contact | Adam Palumbo |
| Correspondent | Adam Palumbo Vortran Medical Technology 1, Inc. 21 Goldenland Court, Suite 100 Sacramento, CA 95834 |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-06 |
| Decision Date | 2021-02-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20637320062001 | K202219 | 000 |