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 K051572
Device Name KOKO LEGEND
Applicant
PULMONARY DATA SERVICES, INC.
908 MAIN STREET
LOUISVILLE,  CO  80027
Applicant Contact DONALD HENTON
Correspondent
PULMONARY DATA SERVICES, INC.
908 MAIN STREET
LOUISVILLE,  CO  80027
Correspondent Contact DONALD HENTON
Regulation Number868.1840
Classification Product Code
BZG  
Date Received06/14/2005
Decision Date 11/17/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-