510(k) K000406
K000406 is an FDA 510(k) premarket notification submitted by Rhino Metrics A/S for the device "RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULE". The FDA issued a decision of Substantially Equivalent on April 17, 2000. The device falls under product code BXQ (Rhinoanemometer (Measurement Of Nasal Decongestion)), a Class II device regulated under 21 CFR 868.1800. Rhino Metrics A/S has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 17, 2000
- Date Received
- February 7, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Rhinoanemometer (Measurement Of Nasal Decongestion)
- Device Class
- Class II
- Regulation Number
- 868.1800
- Review Panel
- AN
- Submission Type