510(k) K010949
K010949 is an FDA 510(k) premarket notification submitted by Agilent Technologies for the device "2010 PLUS HOLTER FOR WINDOWS". The FDA issued a decision of Substantially Equivalent on September 28, 2001. The device falls under product code MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm), a Class II device regulated under 21 CFR 870.2800. Agilent Technologies has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 28, 2001
- Date Received
- March 29, 2001
- 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