The following data is part of a premarket notification filed by Vortran Medical Technology 1, Inc. with the FDA for Vortran Apm-plus.
| Device ID | K182292 |
| 510k Number | K182292 |
| Device Name: | VORTRAN APM-Plus |
| Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Applicant | VORTRAN Medical Technology 1, Inc. 21 Goldenland Court, Suite 100 Sacramento, CA 95834 |
| Contact | James Lee |
| Correspondent | James Lee VORTRAN Medical Technology 1, Inc. 21 Goldenland Court, Suite 100 Sacramento, CA 95834 |
| Product Code | CAP |
| CFR Regulation Number | 868.2600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-23 |
| Decision Date | 2019-09-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10637320039600 | K182292 | 000 |