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, Continuous, Non-Life-Supporting
510(k) Number K231064
Device Name ReddyPort Elbow
Applicant
SMD Manufacturing LLC
918 S 500 W, Ste A
Salt Lake City,  UT  84101
Applicant Contact Jared Spendlove
Correspondent
Lean RAQA, LLC
131 E Loch Lomond Dr.
Oro Valley,  AZ  85737
Correspondent Contact Tianna Benson
Regulation Number868.5895
Classification Product Code
MNS  
Date Received04/14/2023
Decision Date 07/13/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-