510(k) K973875
K973875 is an FDA 510(k) premarket notification submitted by Respironics, Inc. for the device "RINOFLOW MICRONIZED E.N.T. WASH SYSTEM". The FDA issued a decision of Substantially Equivalent on January 26, 1998. The device falls under product code KMA (Irrigator, Powered Nasal), a Class I device regulated under 21 CFR 874.5550. Respironics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 26, 1998
- Date Received
- October 10, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Irrigator, Powered Nasal
- Device Class
- Class I
- Regulation Number
- 874.5550
- Review Panel
- EN
- Submission Type