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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 K864836
Device Name L.A.P. SPIROMETER
Applicant
Timeter Instrument Corp.
2501 Oregon Pike
Lancaster,  PA  17601
Applicant Contact TERRY L LANDIS
Correspondent
Timeter Instrument Corp.
2501 Oregon Pike
Lancaster,  PA  17601
Correspondent Contact TERRY L LANDIS
Regulation Number868.1890
Classification Product Code
BTY  
Date Received12/09/1986
Decision Date 03/06/1987
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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