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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thermometer, Electronic, Clinical
510(k) Number K010502
Device Name MODEL THERMO TEK QUICKCARE
Applicant
SAAT LTD.
1468 HARWELL AVE.
CROFTON,,  MD  21114
Applicant Contact E. J SMITH
Correspondent
ENTELA, INC.
3033 MADISON AVENUE, SE
GRAND RAPIDS,  MI  49548
Correspondent Contact NED DEVINE JR.
Regulation Number880.2910
Classification Product Code
FLL  
Date Received02/21/2001
Decision Date 02/27/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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