510(k) K000406

RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULE by Rhino Metrics A/S — Product Code BXQ

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