510(k) K003763
K003763 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 January 5, 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
- January 5, 2001
- Date Received
- December 6, 2000
- 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