The following data is part of a premarket notification filed by Grass-telefactor Product Group with the FDA for Szac-16 Seizure Analysis Computer.
| Device ID | K870450 |
| 510k Number | K870450 |
| Device Name: | SZAC-16 SEIZURE ANALYSIS COMPUTER |
| Classification | Automatic Event Detection Software For Full-montage Electroencephalograph |
| Applicant | GRASS-TELEFACTOR PRODUCT GROUP UNION HILL BLDG., DEHAVEN ST. W. Conshohocken, PA 19428 |
| Contact | John B Chatten |
| Correspondent | John B Chatten GRASS-TELEFACTOR PRODUCT GROUP UNION HILL BLDG., DEHAVEN ST. W. Conshohocken, PA 19428 |
| Product Code | OMB |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-03 |
| Decision Date | 1987-04-08 |