The following data is part of a premarket notification filed by Chalgren Enterprises, Inc. with the FDA for Reusable Finger Clip Recording Electrode.
| Device ID | K925706 |
| 510k Number | K925706 |
| Device Name: | REUSABLE FINGER CLIP RECORDING ELECTRODE |
| Classification | Electrode, Cutaneous |
| Applicant | CHALGREN ENTERPRISES, INC. 8021 CARMEL ST. SUITE B Gilroy, CA 95020 |
| Contact | Keith Colkitt |
| Correspondent | Keith Colkitt CHALGREN ENTERPRISES, INC. 8021 CARMEL ST. SUITE B Gilroy, CA 95020 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-12 |
| Decision Date | 1993-02-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816020020818 | K925706 | 000 |
| 00816020020801 | K925706 | 000 |
| 00816020020795 | K925706 | 000 |
| 00816020020788 | K925706 | 000 |