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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 K972140
Device Name A1 ACOUSTIC RHINOMETER
Applicant
G.M. INSTRUMENTS LTD.
UNIT 6, ASHGROVE
ASHGROVE ROAD
KILWINNING,  GB KA13 6PU
Applicant Contact E. W GREIG
Correspondent
G.M. INSTRUMENTS LTD.
UNIT 6, ASHGROVE
ASHGROVE ROAD
KILWINNING,  GB KA13 6PU
Correspondent Contact E. W GREIG
Regulation Number868.1800
Classification Product Code
BXQ  
Date Received06/06/1997
Decision Date 09/30/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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