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 Percussor, Powered-Electric
510(k) Number K250860
Device Name BreatheBand® (Model 1000)
Applicant
Exemplar Medical, LLC
4521 Wornall Rd. Suite 106
Kansas City,  MO  64111
Applicant Contact Christian Moore
Correspondent
Exemplar Medical, LLC
4521 Wornall Rd. Suite 106
Kansas City,  MO  64111
Correspondent Contact Christian Moore
Regulation Number868.5665
Classification Product Code
BYI  
Date Received03/21/2025
Decision Date 10/02/2025
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
-
-