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 System, Thermal Regulating
510(k) Number K894980
Device Name BIO-CAL 370 HEATER/COOLER
Applicant
BIO MEDICUS, INC.
9600 W. 76 ST.
EDEN PRAIRIE,  MN  55344
Applicant Contact THOMAS K JOHNSEN
Correspondent
BIO MEDICUS, INC.
9600 W. 76 ST.
EDEN PRAIRIE,  MN  55344
Correspondent Contact THOMAS K JOHNSEN
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received08/08/1989
Decision Date 11/02/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-