K073557 is an FDA 510(k) clearance for the EEG NEUROAMP, MODEL CS10137. This device is classified as a Device, Biofeedback (Class II - Special Controls, product code HCC).
Submitted by Corscience GmbH & Co. KG (Erlangen, Bavaria, DE). The FDA issued a Cleared decision on February 28, 2008, 71 days after receiving the submission on December 19, 2007.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5050.
| 510(k) Number | K073557 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2007 |
| Decision Date | February 28, 2008 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HCC - Device, Biofeedback |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5050 |