510(k) K113045
K113045 is an FDA 510(k) premarket notification submitted by Zephyr Technology Corporation for the device "BIOHARNESS". The FDA issued a decision of Substantially Equivalent on August 14, 2012. The device falls under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.1025. Zephyr Technology Corporation has at least 3 other 510(k) clearances on record.
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