The following data is part of a premarket notification filed by Moberg Research, Inc. with the FDA for Cns Envision.
| Device ID | K192572 |
| 510k Number | K192572 |
| Device Name: | CNS Envision |
| Classification | Non-normalizing Quantitative Electroencephalograph Software |
| Applicant | Moberg Research, Inc. 224 S. Maple Street Ambler, PA 19002 |
| Contact | Anna Rodriguez |
| Correspondent | Anna Rodriguez Moberg Research, Inc. 224 S. Maple Street Ambler, PA 19002 |
| Product Code | OLT |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-18 |
| Decision Date | 2019-12-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B485VIS100 | K192572 | 000 |
| B485CNSENV1000 | K192572 | 000 |