510(k) K003621
K003621 is an FDA 510(k) premarket notification submitted by Agilent Technologies, Inc. for the device "ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE D.0". The FDA issued a decision of Substantially Equivalent on December 20, 2000. The device falls under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.1025. Agilent Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 2000
- Date Received
- November 24, 2000
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Device Class
- Class II
- Regulation Number
- 870.1025
- Review Panel
- CV
- Submission Type