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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Pressure, Gas
510(k) Number K875075
Device Name RT-200 COMPUTER INTERFACE
Applicant
Timeter Instrument Corp.
2501 Oregon Pike
Lancaster,  PA  17601
Applicant Contact ROBERT A FRITZ
Correspondent
Timeter Instrument Corp.
2501 Oregon Pike
Lancaster,  PA  17601
Correspondent Contact ROBERT A FRITZ
Regulation Number868.2620
Classification Product Code
BXX  
Date Received12/09/1987
Decision Date 04/21/1988
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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