510(k) K212657
K212657 is an FDA 510(k) premarket notification submitted by Spectrum Medical , Ltd. for the device "Quantum Heater-Cooler". The FDA issued a decision of Substantially Equivalent on May 6, 2022. The device falls under product code DWC (Controller, Temperature, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4250. Spectrum Medical , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 6, 2022
- Date Received
- August 23, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Controller, Temperature, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4250
- Review Panel
- CV
- Submission Type
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).