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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name spirometer, diagnostic
510(k) Number K860522
Device Name SPIROMETER, MODEL TS-1000, PART NO. SLZ7504
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 Number868.1840
Classification Product Code
BZG  
Date Received02/11/1986
Decision Date 03/03/1986
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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