FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
Hypotension Decision Assist Model HDA-OR2
K Number: K212529
·
Decision Nov 23, 2021
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
176
Applicant Total
2
Review Days
104
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Basic Information
- Device Name
- Hypotension Decision Assist Model HDA-OR2
- K Number
- K212529
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1435
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Directed Systems, Ltd.
- Date Received
- August 11, 2021
- Decision Date
- November 23, 2021
- Product Code
- DXG
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | FDA class 2 | Cardiovascular |
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Other Clearances by Directed Systems, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K190955 | Hypotension Decision Assist | Nov 27, 2019 | Substantially Equivalent |