510(k) K163649
K163649 is an FDA 510(k) premarket notification submitted by Philips Medical Systems for the device "SureSigns VS3; SureSigns VS4". The FDA issued a decision of Substantially Equivalent on March 31, 2017. The device falls under product code DSJ (Alarm, Blood-Pressure), a Class II device regulated under 21 CFR 870.1100. Philips Medical Systems has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 31, 2017
- Date Received
- December 23, 2016
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Alarm, Blood-Pressure
- Device Class
- Class II
- Regulation Number
- 870.1100
- Review Panel
- CV
- Submission Type