• 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 K870163
Device Name BIOCHEM MICROSPAN 1040 OXIMETER
Applicant
BIOCHEM INTERNATIONAL, INC.
W238 N1650 ROCKWOOD DR.
WAUKESHA,  WI  53186
Applicant Contact KEITH R HARPER
Correspondent
BIOCHEM INTERNATIONAL, INC.
W238 N1650 ROCKWOOD DR.
WAUKESHA,  WI  53186
Correspondent Contact KEITH R HARPER
Regulation Number870.2700
Classification Product Code
DQA  
Date Received01/14/1987
Decision Date 03/03/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-