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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rhinoanemometer (Measurement Of Nasal Decongestion)
510(k) Number K000406
Device Name RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULE
Applicant
RHINOMETRICS A/S
555 13TH ST. N.W.
WASHINGTON,  DC  20004 -1109
Applicant Contact HOWARD M HOLSTEIN
Correspondent
RHINOMETRICS A/S
555 13TH ST. N.W.
WASHINGTON,  DC  20004 -1109
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number868.1800
Classification Product Code
BXQ  
Date Received02/07/2000
Decision Date 04/17/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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