The following data is part of a premarket notification filed by Cme Telemetrix, Inc. with the FDA for Wireless Eeg Recording System Model W32.
| Device ID | K963195 |
| 510k Number | K963195 |
| Device Name: | WIRELESS EEG RECORDING SYSTEM MODEL W32 |
| Classification | Encephalogram Telemetry System |
| Applicant | CME TELEMETRIX, INC. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
| Contact | Anne Marie Cesario |
| Correspondent | Anne Marie Cesario CME TELEMETRIX, INC. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
| Product Code | GYE |
| CFR Regulation Number | 882.1855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-15 |
| Decision Date | 1997-07-29 |