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 K862559
Device Name CARBOSTAT, CO2 ANALYZER
Applicant
Elm Street Designs
520 Elm St., #2
San Carlos,  CA  94070
Applicant Contact RONALD B SMERNOFF
Correspondent
Elm Street Designs
520 Elm St., #2
San Carlos,  CA  94070
Correspondent Contact RONALD B SMERNOFF
Regulation Number868.1400
Classification Product Code
CCK  
Date Received07/03/1986
Decision Date 07/15/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-