510(k) K130740
K130740 is an FDA 510(k) premarket notification submitted by Zoe Medical, Inc. for the device "NIGHTINGALE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on Jul 23, 2013. 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. Zoe Medical, Inc. has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 23, 2013
- Date Received
- Mar 19, 2013
- 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
- 510(k)