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 computer, oxygen-uptake
510(k) Number K071533
Device Name FITMATE SERIES
Applicant
COSMED S.R.L.
1129 BLOOMFIELD AVENUE
WEST CALDWELL,  NJ  07000
Applicant Contact ROBERT SCHIFF
Correspondent
COSMED S.R.L.
1129 BLOOMFIELD AVENUE
WEST CALDWELL,  NJ  07000
Correspondent Contact ROBERT SCHIFF
Regulation Number868.1730
Classification Product Code
BZL  
Date Received06/05/2007
Decision Date 09/28/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-