510(k) K163657
K163657 is an FDA 510(k) premarket notification submitted by Spectrum Medical , Ltd. for the device "Quantum Workstation". The FDA issued a decision of Substantially Equivalent on January 18, 2017. The device falls under product code DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4330. Spectrum Medical , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 18, 2017
- Date Received
- December 23, 2016
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4330
- Review Panel
- CV
- Submission Type