The following data is part of a premarket notification filed by Neuroscan with the FDA for Synamps2.
| Device ID | K023771 |
| 510k Number | K023771 |
| Device Name: | SYNAMPS2 |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | NEUROSCAN 7850 PASEO DEL NORTE SUITE 101 El Paso, TX 79912 |
| Contact | Elvira Garcia |
| Correspondent | Elvira Garcia NEUROSCAN 7850 PASEO DEL NORTE SUITE 101 El Paso, TX 79912 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-12 |
| Decision Date | 2003-02-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09342451001580 | K023771 | 000 |
| 09342451001573 | K023771 | 000 |
| 09342451001566 | K023771 | 000 |
| 09342451001559 | K023771 | 000 |
| 09342451001542 | K023771 | 000 |
| 09342451001535 | K023771 | 000 |
| 09342451001528 | K023771 | 000 |
| 09342451001511 | K023771 | 000 |
| 09342451001504 | K023771 | 000 |