Rinoflow Micronized E.N.T. Wash System
FDA 510(k) K973875 · Respironics, Inc.
510(k) numberK973875
Submission
- Device name
- Rinoflow Micronized E.N.T. Wash System
- Applicant
- Respironics, Inc.
Murrysville, PA, US - Received
- October 10, 1997
- Decision date
- January 26, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KMA – Irrigator, Powered Nasal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.5550
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code KMA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K140542 | Navage Nasal Irrigator, Navage Nose CleanerKMA · Traditional | Rhinosystems, Inc. | 06/27/2014SE |
| K963550 | Rinoflow Micronized E.N..T. Wash SytstemKMA · Traditional | Respironics, Inc. | 11/01/1996SE |
| K950078 | Microflow Irrigation SystemKMA · Traditional | Jedmed Instrument Co. | 06/21/1995SE |
| K822351 | Powder BlowersKMA · Traditional | Kelleher Corp. | 09/14/1982SE |
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Questions and answers
When was Rinoflow Micronized E.N.T. Wash System cleared by the FDA?
Rinoflow Micronized E.N.T. Wash System (K973875) received a 510(k) decision of Substantially Equivalent on January 26, 1998, 108 days after the submission was received.
What is the product code of K973875?
The FDA product code is KMA – Irrigator, Powered Nasal, a Class I (low risk) device regulated under 21 CFR 874.5550.