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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Thermal, Infusion Fluid
510(k) Number K882361
Device Name STIHLER ASTOTHERM IFT 200, IFT 220
Applicant
Stihler Electronic, C/O Worldwide Regul. Services
23 Carol Ave.
Farmingville,  NY  11738
Applicant Contact RICHARD LANZILLOTTO
Correspondent
Stihler Electronic, C/O Worldwide Regul. Services
23 Carol Ave.
Farmingville,  NY  11738
Correspondent Contact RICHARD LANZILLOTTO
Regulation Number880.5725
Classification Product Code
LGZ  
Date Received06/07/1988
Decision Date 08/25/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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