510(k) K111487
K111487 is an FDA 510(k) premarket notification submitted by Norav Medical Corp. for the device "NH-301 AMBULATORY ECG ANALYSIS SOFTWARE". The FDA issued a decision of Substantially Equivalent on November 10, 2011. The device falls under product code MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm), a Class II device regulated under 21 CFR 870.2800. Norav Medical Corp. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 10, 2011
- Date Received
- May 31, 2011
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrocardiograph, Ambulatory, With Analysis Algorithm
- Device Class
- Class II
- Regulation Number
- 870.2800
- Review Panel
- CV
- Submission Type