510(k) K020632
K020632 is an FDA 510(k) premarket notification submitted by Mennen Medical , Ltd. for the device "ENGUARD REMOTE PATIENT MONITOR". The FDA issued a decision of Substantially Equivalent on March 15, 2002. The device falls under product code QYX (Outpatient Cardiac Telemetry), a Class II device regulated under 21 CFR 870.1025. Mennen Medical , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 15, 2002
- Date Received
- February 27, 2002
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Outpatient Cardiac Telemetry
- Device Class
- Class II
- Regulation Number
- 870.1025
- Review Panel
- CV
- Submission Type
Devices are intended to continuously record and analyze electrocardiograms for automatic detection and recording of cardiac electrical activity in an outpatient setting. Detected, notifiable events are transmitted to the prescribing clinician during the monitoring period by a 24/7 attended analysis center after review by a qualified individual. Devices may allow remote access and display of electrocardiograms acquired. Not for use for detection or notification of hemodynamically unstable or life-threatening arrhythmias or cardiac events requiring urgent medical response. Not intended for patients at elevated risk of serious cardiovascular events that would require prompt intervention. It is not intended for monitoring patients during cardiac rehabilitation outside of healthcare facilities. Devices are intended for prescription use only.