510(k) K093766
K093766 is an FDA 510(k) premarket notification submitted by Mennen Medical , Ltd. for the device "VITALOGIK 6000/6500". The FDA issued a decision of Substantially Equivalent on May 7, 2010. 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
- May 7, 2010
- Date Received
- December 7, 2009
- 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