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 | K113045 |
| 510k Number | K113045 |
| Device Name: | BIOHARNESS |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | ZEPHYR TECHNOLOGY CORPORATION 1151 HOPE STREET Stamford, CT 06907 |
| Contact | Richard Keen |
| Correspondent | Richard Keen ZEPHYR TECHNOLOGY CORPORATION 1151 HOPE STREET Stamford, CT 06907 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-13 |
| Decision Date | 2012-08-14 |
| Summary: | summary |
Trademark Results [BIOHARNESS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOHARNESS 77245540 3678263 Live/Registered |
Zephyr Technology Limited 2007-08-02 |
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