510(k) K170047
K170047 is an FDA 510(k) premarket notification submitted by Shenzhen Creative Industry Co., Ltd. for the device "All-in-One Health Monitor, PC-303". The FDA issued a decision of Substantially Equivalent on Sep 9, 2017. 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. Shenzhen Creative Industry Co., Ltd. has 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 9, 2017
- Date Received
- Jan 5, 2017
- 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)