KMA — Irrigator, Powered Nasal Class I
FDA product code KMA covers "Irrigator, Powered Nasal", a Class I medical device regulated under 21 CFR 874.5550. Submissions are reviewed by the Ear, Nose, Throat panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KMA
- Device Class
- Class I
- Regulation Number
- 874.5550
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K140542 | rhinosystems | NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANER | June 27, 2014 |
| K973875 | respironics | RINOFLOW MICRONIZED E.N.T. WASH SYSTEM | January 26, 1998 |
| K963550 | respironics | RINOFLOW MICRONIZED E.N..T. WASH SYTSTEM | November 1, 1996 |
| K950078 | jedmed instrument | MICROFLOW IRRIGATION SYSTEM | June 21, 1995 |
| K822351 | kelleher | POWDER BLOWERS | September 14, 1982 |