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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Predicted Values, Pulmonary Function
510(k) Number K855068
Device Name SPIROMETER, MODEL TS-500 PART #SLZ7534
Applicant
TELEDYNE AVIONICS DIV. OF TELEDYNE
P.O. BOX 6400 (RT. 743)
CHARLOTTESVILLE,  VA  22906
Applicant Contact ROBERT L HAMM
Correspondent
TELEDYNE AVIONICS DIV. OF TELEDYNE
P.O. BOX 6400 (RT. 743)
CHARLOTTESVILLE,  VA  22906
Correspondent Contact ROBERT L HAMM
Regulation Number868.1890
Classification Product Code
BTY  
Date Received12/18/1985
Decision Date 02/05/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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