RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULE


definition

Device Classification Name

rhinoanemometer (measurement of nasal decongestion)

510(k) Number K000406
Device Name RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULE
Original Applicant
RHINOMETRICS A/S
555 13th st. n.w.
washington, 
DC 
20004 -1109

Original Contact howard m holstein
Regulation Number 868.1800
Classification Product Code
BXQ  
Date Received 02/07/2000
Decision Date 04/17/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Ear Nose & Throat

Type Traditional
Reviewed by Third Party No

Combination Product

No