The following data is part of a premarket notification filed by Advanced Technology Laboratories, Inc. with the FDA for Neuro Sector Fixation Device.
| Device ID | K833522 |
| 510k Number | K833522 |
| Device Name: | NEURO SECTOR FIXATION DEVICE |
| Classification | Echoencephalograph |
| Applicant | ADVANCED TECHNOLOGY LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GXW |
| CFR Regulation Number | 882.1240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-19 |
| Decision Date | 1984-05-25 |