The following data is part of a premarket notification filed by New England Medical Instruments, Inc. with the FDA for Digitrace(tm) Home Monit Comp/elb(tm) Eeg Lunch Bx.
| Device ID | K910771 |
| 510k Number | K910771 |
| Device Name: | DIGITRACE(TM) HOME MONIT COMP/ELB(TM) EEG LUNCH BX |
| Classification | Automatic Event Detection Software For Full-montage Electroencephalograph |
| Applicant | NEW ENGLAND MEDICAL INSTRUMENTS, INC. 10 PHEASANT LN. Lexington, MA 02173 |
| Contact | John R Ives |
| Correspondent | John R Ives NEW ENGLAND MEDICAL INSTRUMENTS, INC. 10 PHEASANT LN. Lexington, MA 02173 |
| Product Code | OMB |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-22 |
| Decision Date | 1991-12-18 |