Device Type ID | 42 |
Device Name | Meter, Airway Pressure (inspiratory Force) |
Regulation Description | Inspiratory Airway Pressure Meter. |
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 | 868.1780 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | BXR |
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 | 42 |
Device | Meter, Airway Pressure (inspiratory Force) |
Product Code | BXR |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Inspiratory Airway Pressure Meter. |
CFR Regulation Number | 868.1780 [🔎] |