The following data is part of a premarket notification filed by Corscience Gmbh & Co. Kg with the FDA for Eeg Neuroamp, Model Cs10137.
| Device ID | K073557 |
| 510k Number | K073557 |
| Device Name: | EEG NEUROAMP, MODEL CS10137 |
| Classification | Device, Biofeedback |
| Applicant | CORSCIENCE GMBH & CO. KG HENKESTRASSE 91 Erlangen, DE 91052 |
| Contact | Christine Baumann |
| Correspondent | Christine Baumann CORSCIENCE GMBH & CO. KG HENKESTRASSE 91 Erlangen, DE 91052 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-19 |
| Decision Date | 2008-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04251341900047 | K073557 | 000 |
| 04251341900023 | K073557 | 000 |
| 04251341900016 | K073557 | 000 |