DeltaScan Monitor
FDA 510(k) clearance K222680 · decided 2023-02-02
Clearance details
- K-number
- K222680
- Device name
- DeltaScan Monitor
- Applicant
- Prolira B.V.
- Decision
- Substantially Equivalent
- Date received
- 2022-09-06
- Decision date
- 2023-02-02
- Days to decision
- 149 days
- Clearance type
- Traditional
- Product code
- NCG
- Device class
- 2
- Regulation number
- 882.1440
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Utrecht, NL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Ceribell Delirium Monitor System (K251936) | Ceribell, Inc. | 2025-12-08 |
| NEBA SYSTEM (DEN110019) | Lexicor Medical Technology, LLC | 2013-07-15 |
Recalls involving this device
No recalls on record reference this clearance.