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 oximeter
510(k) Number K941289
Device Name PULSE OXIMETER
Applicant
BCI INTL., INC.
W238 N1650 ROCKWOOD DR.
WAUKESHA,  WI  53188
Applicant Contact SCOTT J PEASE
Correspondent
BCI INTL., INC.
W238 N1650 ROCKWOOD DR.
WAUKESHA,  WI  53188
Correspondent Contact SCOTT J PEASE
Regulation Number870.2700
Classification Product Code
DQA  
Date Received03/17/1994
Decision Date 06/22/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-