510(k) K920445
K920445 is an FDA 510(k) premarket notification submitted by Siemens Medical Electronics for the device "SIEMENS SIRECUST PENTA SYSTEM AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on March 2, 1993. 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 Electronics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 2, 1993
- Date Received
- February 4, 1992
- 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