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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Pulmonary Function Data
510(k) Number K855070
Device Name SPIROMETER MODEL TS-200 SLZ 7541
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 Number868.1880
Classification Product Code
BZC  
Date Received12/18/1985
Decision Date 01/30/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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