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-Monoxide, Gaseous-Phase
510(k) Number K902113
Device Name VITALOGRAPH - BREATHCO MONITOR
Applicant
MCNEILL INTL., INC.
2904 BISHOP RD.
WILLOUGHBY,  OH  44092
Applicant Contact ALLAN MCNEILL
Correspondent
MCNEILL INTL., INC.
2904 BISHOP RD.
WILLOUGHBY,  OH  44092
Correspondent Contact ALLAN MCNEILL
Regulation Number868.1430
Classification Product Code
CCJ  
Date Received05/11/1990
Decision Date 10/26/1990
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
-
-