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 monitor, physiological, patient (without arrhythmia detection or alarms)
510(k) Number K180734
Device Name SmartLinx Vitals Plus Patient Monitoring System
Applicant
Capsule Technologie
300 Brickstone Square, Suite 203
Andover,  MA  01810
Applicant Contact Maylin Truesdell
Correspondent
Capsule Technologie
300 Brickstone Square, Suite 203
Andover,  MA  01810
Correspondent Contact Maylin Truesdell
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Codes
DQA   DXN   FLL  
Date Received03/20/2018
Decision Date 08/08/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-