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 K242798
Device Name Airmod
Applicant
Heroic Faith International Ltd.
18F., No. 460, Sec. 4, Xinyi Rd., Xinyi Dist.
Taipei City,  TW 110
Applicant Contact Cheng Yuan-ren
Correspondent
RQM+
2790 Mosside Blvd, Suite 800
Monroeville,  PA  15146
Correspondent Contact Pierre Bounaud
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received09/16/2024
Decision Date 02/28/2025
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
-
-