The following data is part of a premarket notification filed by New England Medical Instruments, Inc. with the FDA for Digitrace Home Video System.
| Device ID | K955787 |
| 510k Number | K955787 |
| Device Name: | DIGITRACE HOME VIDEO SYSTEM |
| Classification | Automatic Event Detection Software For Full-montage Electroencephalograph |
| Applicant | NEW ENGLAND MEDICAL INSTRUMENTS, INC. 286 CONGRESS ST. Boston, MA 02210 |
| Contact | Peter B Leone |
| Correspondent | Peter B Leone NEW ENGLAND MEDICAL INSTRUMENTS, INC. 286 CONGRESS ST. Boston, MA 02210 |
| Product Code | OMB |
| Subsequent Product Code | GWQ |
| Subsequent Product Code | OLV |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-21 |
| Decision Date | 1996-02-09 |