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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K950854
Device Name VITALOGRAPH 2110 SOFTWARE INTERFACE
Applicant
Vitalograph , Ltd.
8347 Quivira Rd.
Lenexa,  KS  66215
Applicant Contact PHIL HEMES
Correspondent
Vitalograph , Ltd.
8347 Quivira Rd.
Lenexa,  KS  66215
Correspondent Contact PHIL HEMES
Regulation Number870.2800
Classification Product Code
DSH  
Date Received02/27/1995
Decision Date 10/12/1995
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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