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 ventilatory effort recorder
510(k) Number K151433
Device Name AUDICOR CA300/CC100 Analyzer with SDB
Applicant
INOVISE MEDICAL, INC.
8770 SW NIMBUS AVENUE
SUITE D
BEAVERTON,  OR  97008
Applicant Contact Earl Anderson
Correspondent
INOVISE MEDICAL, INC.
8770 SW NIMBUS AVENUE
SUITE D
BEAVERTON,  OR  97008
Correspondent Contact Earl Anderson
Regulation Number868.2375
Classification Product Code
MNR  
Subsequent Product Code
MLO  
Date Received05/28/2015
Decision Date 03/18/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-