| Device Type ID | 30 |
| Device Name | Spirometer, Therapeutic (incentive) |
| Regulation Description | Incentive Spirometer. |
| 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 | 868.5690 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | BWF |
| 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 | 30 |
| Device | Spirometer, Therapeutic (incentive) |
| Product Code | BWF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Incentive Spirometer. |
| CFR Regulation Number | 868.5690 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ACTEGY LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BESMED HEALTH BUSINESS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
PRE HOLDING, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Leak / Splash | 11 |
Device Operates Differently Than Expected | 9 |
Physical Resistance / Sticking | 4 |
Air Leak | 4 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Misassembled | 1 |
Occlusion Within Device | 1 |
Data Problem | 1 |
Sticking | 1 |
Restricted Flow Rate | 1 |
Mechanical Problem | 1 |
| Total Device Problems | 36 |