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 Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
510(k) Number K991086
Device Name CAPNOCHECK II, MODEL 8400
Applicant
Bci Intl., Inc.
N7 W22025 Johnson Rd.
Waukesha,  WI  53186
Applicant Contact DONALD ALEXANDER
Correspondent
Bci Intl., Inc.
N7 W22025 Johnson Rd.
Waukesha,  WI  53186
Correspondent Contact DONALD ALEXANDER
Regulation Number868.1400
Classification Product Code
CCK  
Date Received03/31/1999
Decision Date 06/09/1999
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
Recalls CDRH Recalls
-
-