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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name analyzer, gas, water vapor, gaseous-phase
510(k) Number K771510
Device Name SERVO-PAK MOLEL 0030
Applicant
ISOTHERMAL SYSTEMS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ISOTHERMAL SYSTEMS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.1975
Classification Product Code
BXA  
Date Received08/05/1977
Decision Date 08/16/1977
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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