510(k) K112962
K112962 is an FDA 510(k) premarket notification submitted by Spacelabs Medical, Inc. for the device "SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)". The FDA issued a decision of Substantially Equivalent on November 2, 2011. 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. Spacelabs Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 2, 2011
- Date Received
- October 5, 2011
- 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