| Device Type ID | 147 |
| Device Name | Ventilatory Effort Recorder |
| Regulation Description | Breathing Frequency Monitor. |
| Regulation Medical Specialty | Anesthesiology |
| Review Panel | Anesthesiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 868.2375 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MNR |
| 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 | 147 |
| Device | Ventilatory Effort Recorder |
| Product Code | MNR |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Breathing Frequency Monitor. |
| CFR Regulation Number | 868.2375 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ADVANCED BRAIN MONITORING | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INOVISE MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ITAMAR MEDICAL LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NATUS MEDICAL INCORPORATED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RESMED CORP | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SALTER LABS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SOMNOMEDICS GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WATERMARK MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Battery Problem | 3 |
Improper Or Incorrect Procedure Or Method | 1 |
Burst Container Or Vessel | 1 |
Sparking | 1 |
Electrical /Electronic Property Problem | 1 |
No Audible Alarm | 1 |
Device Issue | 1 |
Temperature Problem | 1 |
| Total Device Problems | 10 |