The following data is part of a premarket notification filed by Compumedics Limited with the FDA for Compumedics Grael System, Models: Grael, Grael Ecg.
| Device ID | K093223 |
| 510k Number | K093223 |
| Device Name: | COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | COMPUMEDICS LIMITED 30-40 FLOCKHART STREET Abbotsford, Victoria, AU 3067 |
| Contact | Stuart King |
| Correspondent | Stuart King COMPUMEDICS LIMITED 30-40 FLOCKHART STREET Abbotsford, Victoria, AU 3067 |
| Product Code | GWQ |
| Subsequent Product Code | OLV |
| Subsequent Product Code | OLZ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-13 |
| Decision Date | 2010-01-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09342451001924 | K093223 | 000 |
| 09342451001245 | K093223 | 000 |
| 09342451001252 | K093223 | 000 |
| 09342451001269 | K093223 | 000 |
| 09342451001276 | K093223 | 000 |
| 09342451001283 | K093223 | 000 |
| 09342451001290 | K093223 | 000 |
| 09342451001306 | K093223 | 000 |
| 09342451001313 | K093223 | 000 |
| 09342451001771 | K093223 | 000 |
| 09342451001825 | K093223 | 000 |
| 09342451001832 | K093223 | 000 |
| 09342451001849 | K093223 | 000 |
| 09342451001856 | K093223 | 000 |
| 09342451001863 | K093223 | 000 |
| 09342451001870 | K093223 | 000 |
| 09342451001894 | K093223 | 000 |
| 09342451001917 | K093223 | 000 |
| 09342451001238 | K093223 | 000 |