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 Pump, Breast, Powered
510(k) Number K161532
Device Name Philips Avent Comfort Single/Twin Electric Breast Pump
Applicant
Philips Consumer Lifestyle - Innovation Site Eindhoven
High Tech Campus 37
Eindhoven,  NL 5656 AE
Applicant Contact Marta Walker
Correspondent
Philips Consumer Lifestyle - Innovation Site Eindhoven
High Tech Campus 37
Eindhoven,  NL 5656 AE
Correspondent Contact Marta Walker
Regulation Number884.5160
Classification Product Code
HGX  
Date Received06/02/2016
Decision Date 08/29/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-