| Device Type ID | 90 |
| Device Name | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Regulation Description | Airway Pressure Monitor. |
| Regulation Medical Specialty | Anesthesiology |
| Review Panel | Anesthesiology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Respiratory Devices Branch (RPDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 868.2600 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | CAP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 90 |
| Device | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Product Code | CAP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Airway Pressure Monitor. |
| CFR Regulation Number | 868.2600 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BESMED HEALTH BUSINESS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VORTRAN MEDICAL TECHNOLOGY 1, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WESTMED HOLDING CO. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WESTMED, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Output Problem | 3 |
| Total Device Problems | 3 |