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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Pressure, Catheter Tip
510(k) Number K882031
Device Name VITALERT 2000 VITAL SIGNS MONITOR
Applicant
Draeger Medical, Inc.
148 B. Quarry Rd.
Telford,  PA  18969
Applicant Contact PAUL D DOUGHERTY
Correspondent
Draeger Medical, Inc.
148 B. Quarry Rd.
Telford,  PA  18969
Correspondent Contact PAUL D DOUGHERTY
Regulation Number870.2870
Classification Product Code
DXO  
Date Received05/16/1988
Decision Date 07/28/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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