The following data is part of a premarket notification filed by Chalgren Enterprises, Inc. with the FDA for Reusable Dual Disc Bar Recording Electrodes.
| Device ID | K923665 |
| 510k Number | K923665 |
| Device Name: | REUSABLE DUAL DISC BAR RECORDING ELECTRODES |
| Classification | Device, Nerve Conduction Velocity Measurement |
| Applicant | CHALGREN ENTERPRISES, INC. 8021 CARMEL ST. SUITE B Gilroy, CA 95020 |
| Contact | Richard Kaiser |
| Correspondent | Richard Kaiser CHALGREN ENTERPRISES, INC. 8021 CARMEL ST. SUITE B Gilroy, CA 95020 |
| Product Code | JXE |
| CFR Regulation Number | 882.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-22 |
| Decision Date | 1992-10-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816020020658 | K923665 | 000 |
| 00816020020641 | K923665 | 000 |