510(k) K212529
K212529 is an FDA 510(k) premarket notification submitted by Directed Systems, Ltd. for the device "Hypotension Decision Assist Model HDA-OR2". The FDA issued a decision of Substantially Equivalent on November 23, 2021. The device falls under product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function), a Class II device regulated under 21 CFR 870.1435. Directed Systems, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 23, 2021
- Date Received
- August 11, 2021
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer, Diagnostic, Pre-Programmed, Single-Function
- Device Class
- Class II
- Regulation Number
- 870.1435
- Review Panel
- CV
- Submission Type