The following data is part of a premarket notification filed by Compumedics Usa, Ltd. with the FDA for Compumedics Neuvo.
| Device ID | K081151 |
| 510k Number | K081151 |
| Device Name: | COMPUMEDICS NEUVO |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | COMPUMEDICS USA, LTD. 6605 WEST WT HARRIS BLVD SUITE F Charlotte, NC 28269 |
| Contact | David Cardona |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | GWQ |
| Subsequent Product Code | GWE |
| Subsequent Product Code | GWF |
| Subsequent Product Code | GWJ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-04-23 |
| Decision Date | 2008-09-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09342451001207 | K081151 | 000 |
| 09342451001030 | K081151 | 000 |
| 09342451001047 | K081151 | 000 |
| 09342451001054 | K081151 | 000 |
| 09342451001061 | K081151 | 000 |
| 09342451001078 | K081151 | 000 |
| 09342451001085 | K081151 | 000 |
| 09342451001092 | K081151 | 000 |
| 09342451001108 | K081151 | 000 |
| 09342451001115 | K081151 | 000 |
| 09342451001122 | K081151 | 000 |
| 09342451001139 | K081151 | 000 |
| 09342451001146 | K081151 | 000 |
| 09342451001153 | K081151 | 000 |
| 09342451001160 | K081151 | 000 |
| 09342451001177 | K081151 | 000 |
| 09342451001184 | K081151 | 000 |
| 09342451001023 | K081151 | 000 |