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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K100040
Device Name BIOHARNESS
Applicant
Zephyr Technology Corporation
1 Annapolis St.
Suite 200
Annapolis,  MD  21401
Applicant Contact CODE CUBITT
Correspondent
Zephyr Technology Corporation
1 Annapolis St.
Suite 200
Annapolis,  MD  21401
Correspondent Contact CODE CUBITT
Regulation Number870.1025
Classification Product Code
MHX  
Date Received01/07/2010
Decision Date 12/03/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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