510(k) K110463
K110463 is an FDA 510(k) premarket notification submitted by Norav Medical , Ltd. for the device "PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS)". The FDA issued a decision of Substantially Equivalent on November 10, 2011. The device falls under product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.2300. Norav Medical , Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 10, 2011
- Date Received
- February 17, 2011
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Device Class
- Class II
- Regulation Number
- 870.2300
- Review Panel
- CV
- Submission Type