510(k) K030657
K030657 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions for the device "SIEMENS INFINITY GATEWAY SUITE, MODEL VF2". The FDA issued a decision of Substantially Equivalent on Mar 21, 2003. 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. Siemens Medical Solutions has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 21, 2003
- Date Received
- Mar 3, 2003
- 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