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 Gas-Machine, Anesthesia
510(k) Number K191027
Device Name Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System
Applicant
Maquet Critical Care AB
Rontgenvagen 2
Solna,  SE 17154
Applicant Contact Kribu Valdre
Correspondent
Getinge
45 Barbour Pond Drive
Wayne,  NJ  07470
Correspondent Contact Mark N. Smith
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received04/18/2019
Decision Date 03/18/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-