EEG NEUROAMP, MODEL CS10137
FDA 510(k) clearance K073557 · decided 2008-02-28
Clearance details
- K-number
- K073557
- Device name
- EEG NEUROAMP, MODEL CS10137
- Applicant
- Corscience GmbH & Co. KG
- Decision
- Substantially Equivalent
- Date received
- 2007-12-19
- Decision date
- 2008-02-28
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- HCC
- Device class
- 2
- Regulation number
- 882.5050
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Erlangen, Bavaria, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation recall (Z-0526-2013) | EEG Info | 2012-12-17 |