The following data is part of a premarket notification filed by Western Systems Research, Inc. with the FDA for Engplus.
| Device ID | K010059 |
| 510k Number | K010059 |
| Device Name: | ENGPLUS |
| Classification | Nystagmograph |
| Applicant | WESTERN SYSTEMS RESEARCH, INC. 260 S. LOS ROBLES AVE. STE 106 Pasadena, CA 91101 |
| Contact | Linda Davis-o'leary |
| Correspondent | Linda Davis-o'leary WESTERN SYSTEMS RESEARCH, INC. 260 S. LOS ROBLES AVE. STE 106 Pasadena, CA 91101 |
| Product Code | GWN |
| CFR Regulation Number | 882.1460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-08 |
| Decision Date | 2001-02-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B435EV2000 | K010059 | 000 |
| B435ENGEV2000 | K010059 | 000 |