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510(k) K113045

BIOHARNESS by Zephyr Technology Corporation — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2012
Date Received
October 13, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances by Zephyr Technology Corporation

  • K122763 — PHYSIOLOGICAL DATA PROCESSOR (June 20, 2013)
  • K123658 — BIOMODULE 3-M1 (April 24, 2013)
  • K100040 — BIOHARNESS (December 3, 2010)

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