The following data is part of a premarket notification filed by Vortran Medical Technology 1, Inc. with the FDA for Vortran Go2vent.
| Device ID | K162968 |
| 510k Number | K162968 |
| Device Name: | VORTRAN GO2VENT |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | VORTRAN MEDICAL TECHNOLOGY 1, INC. 21 GOLDENLAND COURT, #100 Sacramento, CA 95834 |
| Contact | James Lee |
| Correspondent | James Lee VORTRAN MEDICAL TECHNOLOGY 1, INC. 21 GOLDENLAND COURT, #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 | 2016-10-24 |
| Decision Date | 2017-04-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10637320000112 | K162968 | 000 |
| 20637320060014 | K162968 | 000 |