510(k) K161667
K161667 is an FDA 510(k) premarket notification submitted by Q Core Medical , Ltd. for the device "Sapphire Infusion Pump". The FDA issued a decision of Substantially Equivalent on Mar 27, 2017. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Q Core Medical , Ltd. has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 27, 2017
- Date Received
- Jun 16, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type
- 510(k)