| Device Type ID | 1584 |
| Device Name | Irrigator, Powered Nasal |
| Regulation Description | Powered Nasal Irrigator. |
| Regulation Medical Specialty | Ear Nose & Throat |
| Review Panel | Ear Nose & Throat |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Ear, Nose, And Throat Devices Branch (ENTB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 874.5550 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KMA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1584 |
| Device | Irrigator, Powered Nasal |
| Product Code | KMA |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Powered Nasal Irrigator. |
| CFR Regulation Number | 874.5550 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
RHINOSYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 1 |