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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Cleaning, For Endoscope
510(k) Number K181472
Device Name AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor
Applicant
Advanced Sterilization Products (Asp)
33 Technology Dr.
Irvin,  CA  92618
Applicant Contact Andrea L. Ruth
Correspondent
Advanced Sterilization Products (Asp)
33 Technology Dr.
Irvin,  CA  92618
Correspondent Contact Laurie E Cartwright
Regulation Number876.1500
Classification Product Code
FEB  
Subsequent Product Codes
JOJ   MED  
Date Received06/04/2018
Decision Date 04/23/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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