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 needle, conduction, anesthetic (w/wo introducer)
510(k) Number K192914
Device Name Stimuplex Onvision System
Applicant
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best,  NL 5684 PC
Applicant Contact Gert de Vries
Correspondent
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best,  NL 5684 PC
Correspondent Contact Gert de Vries
Regulation Number868.5150
Classification Product Code
BSP  
Subsequent Product Code
IYO  
Date Received10/15/2019
Decision Date 05/27/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-