The following data is part of a premarket notification filed by Vortran Medical Technology 1, Inc. with the FDA for Vortran Manometer.
| Device ID | K153733 |
| 510k Number | K153733 |
| Device Name: | VORTRAN Manometer |
| Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| 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 | CAP |
| CFR Regulation Number | 868.2600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-28 |
| Decision Date | 2016-09-16 |
| Summary: | summary |