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 Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
510(k) Number K180902
Device Name MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly
Applicant
Medipines Corporation
155 N. Riverview Dr.
Anaheim Hill,  CA  92808
Applicant Contact Steve Lee
Correspondent
Medipines Corporation
155 N. Riverview Dr.
Anaheim Hill,  CA  92808
Correspondent Contact Timothy Marcum
Regulation Number868.1400
Classification Product Code
CCK  
Subsequent Product Codes
BZL   CCL   DQA  
Date Received04/06/2018
Decision Date 01/11/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-