510(k) K201142
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 25, 2021
- Date Received
- April 29, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type
Reconstitute and transfer antineoplastic and other hazardous drugs in healthcare setting indicated to reduce exposure of healthcare personnel to chemotherapy agents in healthcare setting.