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 K013171
Device Name 3420 DIGIT PULSE OXIMETER, MODEL 3420
Applicant
BCI, INC.
N7 W22025 JOHNSON RD.
WAUKESHA,  WI  53186
Applicant Contact DONALD ALEXANDER
Correspondent
BCI, INC.
N7 W22025 JOHNSON RD.
WAUKESHA,  WI  53186
Correspondent Contact DONALD ALEXANDER
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/24/2001
Decision Date 01/03/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-