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 Mixer, Breathing Gases, Anesthesia Inhalation
510(k) Number K161718
Device Name MaxBlend 2, MaxBlend Lite
Applicant
Maxtec, LLC
2305 S 1070 W
Salt Lake City,  UT  84119
Applicant Contact Bruce Brierley
Correspondent
Maxtec, LLC
2305 S 1070 W
Salt Lake City,  UT  84119
Correspondent Contact Paul Dryden
Regulation Number868.5330
Classification Product Code
BZR  
Subsequent Product Code
CCL  
Date Received06/22/2016
Decision Date 10/27/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-