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 Meter, Peak Flow, Spirometry
510(k) Number K172804
Device Name Besmed Peak Flow Meter
Applicant
Besmed Health Business Corp.
No.5, Lane 116, Wu-Kong 2nd Rd
Wu-Ku District,  TW
Applicant Contact Lawrence Wu
Correspondent
Besmed Health Business Corp.
No.5, Lane 116, Wu-Kong 2nd Rd
Wu-Ku District,  TW
Correspondent Contact Paul Dryden
Regulation Number868.1860
Classification Product Code
BZH  
Date Received09/18/2017
Decision Date 01/11/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-