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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name spirometer, diagnostic
510(k) Number K900331
Device Name TUBA TM (TRANSIT-TIME ULTRASONIC BREATH ANALYZER)
Applicant
GHG MEDIZIN-ELEKTRONIK AG
MAINAUSTRASSE 15
ZURICH Z H,  CH 8008
Applicant Contact MANFRED HASLER
Correspondent
GHG MEDIZIN-ELEKTRONIK AG
MAINAUSTRASSE 15
ZURICH Z H,  CH 8008
Correspondent Contact MANFRED HASLER
Regulation Number868.1840
Classification Product Code
BZG  
Date Received01/23/1990
Decision Date 09/04/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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