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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Regulator, Vacuum
510(k) Number K875074
Device Name VACUMATE INTERMITTENT/CONTINUOUS CONTROLLER,VM2000
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 Number880.6740
Classification Product Code
KDP  
Date Received12/09/1987
Decision Date 02/22/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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