510(k) K151839
K151839 is an FDA 510(k) premarket notification submitted by Amc Health for the device "AMC Health VitalCaregiving System". The FDA issued a decision of Substantially Equivalent on September 9, 2016. 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. Amc Health has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 9, 2016
- Date Received
- July 6, 2015
- 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