510(k) K012226
K012226 is an FDA 510(k) premarket notification submitted by Schiller AG for the device "MONITORING SYSTEM,MODEL ARGUS PB-1000". The FDA issued a decision of Substantially Equivalent on April 8, 2002. 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. Schiller AG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 8, 2002
- Date Received
- July 16, 2001
- Clearance Type
- Traditional
- 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