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 Ventilator, Emergency, Powered (Resuscitator)
510(k) Number K161420
Device Name MOVES SLC
Applicant
Thornhill Research, Inc.
210 Dundas St. W.
Suite 200
Toronto,  CA m5g 2e8
Applicant Contact KIPTON LADE
Correspondent
Thornhill Research, Inc.
210 Dundas St. W.
Suite 200
Toronto,  CA m5g 2e8
Correspondent Contact KIPTON LADE
Regulation Number868.5925
Classification Product Code
BTL  
Subsequent Product Codes
BTA   CAW   MWI  
Date Received05/23/2016
Decision Date 06/06/2017
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
-
-