BIOHARNESS

Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

ZEPHYR TECHNOLOGY CORPORATION

The following data is part of a premarket notification filed by Zephyr Technology Corporation with the FDA for Bioharness.

Pre-market Notification Details

• Device ID: K100040
• 510k Number: K100040
• Device Name: BIOHARNESS
• Classification: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
• Applicant: ZEPHYR TECHNOLOGY CORPORATION 1 ANNAPOLIS STREET, SUITE 200 Annapolis, MD 21401
• Contact: Code Cubitt
• Correspondent: Code Cubitt; ZEPHYR TECHNOLOGY CORPORATION 1 ANNAPOLIS STREET, SUITE 200 Annapolis, MD 21401
• Product Code: MHX
• CFR Regulation Number: 870.1025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-01-07
• Decision Date: 2010-12-03
• Summary: summary