510(k) K153335
K153335 is an FDA 510(k) premarket notification submitted by Alertwatch, LLC for the device "AlertWatch: OR". The FDA issued a decision of Substantially Equivalent on March 15, 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. Alertwatch, LLC has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 15, 2016
- Date Received
- November 19, 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