510(k) K030419
K030419 is an FDA 510(k) premarket notification submitted by Viterion Telehealthcare, LLC for the device "VITERION 100 TELEHEALTH MONITOR". The FDA issued a decision of Substantially Equivalent on November 6, 2003. The device falls under product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.2300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 6, 2003
- Date Received
- February 10, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Device Class
- Class II
- Regulation Number
- 870.2300
- Review Panel
- CV
- Submission Type