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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 K860181
Device Name MODEL MR-30 HOLTER RECORDER
Applicant
Oxford Medilog, Inc.
11526 53rd. St. N.
Clearwater,  FL  33520
Applicant Contact MICHAEL J SMITH
Correspondent
Oxford Medilog, Inc.
11526 53rd. St. N.
Clearwater,  FL  33520
Correspondent Contact MICHAEL J SMITH
Regulation Number870.2800
Classification Product Code
DSH  
Date Received01/21/1986
Decision Date 02/26/1986
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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