510(k) K131897
K131897 is an FDA 510(k) premarket notification submitted by Vales & Hills Biomedical Tech. , Ltd. for the device "CV3000 HOLTER ANALYSIS SYSTEM". The FDA issued a decision of Substantially Equivalent on November 26, 2013. The device falls under product code MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm), a Class II device regulated under 21 CFR 870.2800. Vales & Hills Biomedical Tech. , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 26, 2013
- Date Received
- June 25, 2013
- Clearance Type
- Traditional
- 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