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 calculator, pulmonary function data
510(k) Number K183567
Device Name Vyntus/SentrySuite Product Line
Applicant
Vyaire Medical
Leibnizstrasse 7
Hoechberg,  DE 97204
Applicant Contact Elmar Niedermeyer
Correspondent
Vyaire Medical
Leibnizstrasse 7
Hoechberg,  DE 97204
Correspondent Contact Elmar Niedermeyer
Regulation Number868.1880
Classification Product Code
BZC  
Subsequent Product Codes
DPS   MLC   MWI  
Date Received12/21/2018
Decision Date 08/23/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-