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 Monitor, Breathing Frequency
510(k) Number K253274
Device Name BedDot (G1)
Applicant
Intelligent Dots, LLC
147 Technology Pkwy.
Peachtree Corner,  GA  30092
Applicant Contact Wezhan Song
Correspondent
Abmed Medical Technology, Inc.
800 E. Wishkah St., Suite 1021
Aberdeen,  WA  98520
Correspondent Contact Boyle Wang
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received09/29/2025
Decision Date 06/25/2026
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
-
-