The following data is part of a premarket notification filed by New England Medical Instruments, Inc. with the FDA for Mcseer/micro Controller Sld St Eeg Event Recorder.
| Device ID | K910279 |
| 510k Number | K910279 |
| Device Name: | MCSEER/MICRO CONTROLLER SLD ST EEG EVENT RECORDER |
| Classification | Full-montage Standard 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 | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-23 |
| Decision Date | 1991-09-04 |