The following data is part of a premarket notification filed by Vortran Medical Technology 1, Inc. with the FDA for Vortran Airway Pressure Monitor (vapm)-adult, Vortran Airway Pressure Monitor (vapm)- Pediatric.
| Device ID | K103639 |
| 510k Number | K103639 |
| Device Name: | VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRIC |
| Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Applicant | VORTRAN MEDICAL TECHNOLOGY 1, INC. 21 GOLDEN LAND COURT Sacramento, CA 95834 |
| Contact | James Lee |
| Correspondent | James Lee VORTRAN MEDICAL TECHNOLOGY 1, INC. 21 GOLDEN LAND COURT 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 | 2010-12-13 |
| Decision Date | 2011-09-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20637320039003 | K103639 | 000 |