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 Spirometer, Diagnostic
510(k) Number K042058
Device Name ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN
Applicant
CLEMENT CLARKE INTL., LTD.
EDINBURGH WAY
HARLOW, ESSEX,  GB CM20 2TT
Applicant Contact PHILIP HALLYBONE
Correspondent
CLEMENT CLARKE INTL., LTD.
EDINBURGH WAY
HARLOW, ESSEX,  GB CM20 2TT
Correspondent Contact PHILIP HALLYBONE
Regulation Number868.1840
Classification Product Code
BZG  
Date Received07/30/2004
Decision Date 03/23/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-