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 Device, Anti-Snoring
510(k) Number K232735
Device Name EMA 3D
Applicant
Ema Sleep Incorporated
27005 Masters Pkwy.
Spicewood,  TX  78669
Applicant Contact Joseph Frantz
Correspondent
Fishermed Consulting, LLC
820 Civic Center Dr.
Santa Clara,  CA  95050
Correspondent Contact Cheryl Fisher
Regulation Number872.5570
Classification Product Code
LRK  
Subsequent Product Code
LQZ  
Date Received09/07/2023
Decision Date 05/03/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-