Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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 Drive
Irvine,  CA  92618
Applicant Contact Andrea L. Ruth
Correspondent
Advanced Sterilization Products (ASP)
33 Technology Drive
Irvine,  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
-
-