510(k) K011784
K011784 is an FDA 510(k) premarket notification submitted by Mennen Medical , Ltd. for the device "MODIFICATION TO ENVOY PATIENT MONITOR". The FDA issued a decision of Substantially Equivalent on August 16, 2001. The device falls under product code DSI (Detector And Alarm, Arrhythmia), 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
- August 16, 2001
- Date Received
- June 8, 2001
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Detector And Alarm, Arrhythmia
- Device Class
- Class II
- Regulation Number
- 870.1025
- Review Panel
- CV
- Submission Type