510(k) K051730
K051730 is an FDA 510(k) premarket notification submitted by Global Instrumentation, LLC for the device "MATRIX HOLTER SYSTEM, MODEL M12". The FDA issued a decision of Substantially Equivalent on September 26, 2005. The device falls under product code MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm), a Class II device regulated under 21 CFR 870.2800. Global Instrumentation, LLC has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 26, 2005
- Date Received
- June 27, 2005
- Clearance Type
- Abbreviated
- 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