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 System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K151520
Device Name Oscar 2
Applicant
SunTech Medical, Inc.
507 Airport Blvd, Suite 117
Morrisville,  NC  27560
Applicant Contact Charles Setzer
Correspondent
SunTech Medical, Inc.
507 Airport Blvd, Suite 117
Morrisville,  NC  27560
Correspondent Contact Charles Setzer
Regulation Number870.1130
Classification Product Code
DXN  
Date Received06/05/2015
Decision Date 02/19/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-