SPARK Scan
FDA 510(k) clearance K231457 · decided 2023-08-18
Clearance details
- K-number
- K231457
- Device name
- SPARK Scan
- Applicant
- Spark Neuro, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-05-19
- Decision date
- 2023-08-18
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- GWQ
- Device class
- 2
- Regulation number
- 882.1400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- New York, NY, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| Q21 (K221959) | Neurofield, Inc. | 2023-08-31 |
| Cumulus Functional Neurophysiology Platform (K221963) | Cumulus Neuroscience Limited | 2023-04-27 |
| Okti (K230073) | Compumedics Limited | 2023-02-09 |
| Neuronaute with IceCap 2 & IceCap 2 Small (K223644) | Bioserenity | 2023-01-12 |
| iSyncWave (K220056) | iMediSync, Inc. | 2022-08-10 |
| Seer Home (K212788) | Seer Medical Pty, Ltd. | 2022-06-16 |
| WAVi SCAN EEG System and Accessories (K213900) | Wavi Co. | 2022-05-06 |
| NeuroAmp II, NeuroAmp II.5s (K193159) | Corscience GmbH & Co. KG | 2020-12-30 |
Recalls involving this device
No recalls on record reference this clearance.