K973875 is an FDA 510(k) clearance for the RINOFLOW MICRONIZED E.N.T. WASH SYSTEM. This device is classified as a Irrigator, Powered Nasal (Class I - General Controls, product code KMA).
Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on January 26, 1998, 108 days after receiving the submission on October 10, 1997.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.5550.
| 510(k) Number | K973875 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 10, 1997 |
| Decision Date | January 26, 1998 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | KMA — Irrigator, Powered Nasal |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.5550 |