| Device Type ID | 75 |
| Device Name | Monitor, Breathing Frequency |
| Regulation Description | Breathing Frequency 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 | 868.2375 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | BZQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 75 |
| Device | Monitor, Breathing Frequency |
| Product Code | BZQ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Breathing Frequency Monitor. |
| CFR Regulation Number | 868.2375 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
EARLYSENSE LTD. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
HILL-ROM, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MASIMO CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PHILIPS MEDICAL SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PNEUMACARE LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |