The following data is part of a premarket notification filed by Chalgren Enterprises, Inc. with the FDA for Emg Disc Recording Electrode.
Device ID | K953354 |
510k Number | K953354 |
Device Name: | EMG DISC RECORDING ELECTRODE |
Classification | Electrode, Cutaneous |
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 | GXY |
CFR Regulation Number | 882.1320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-07-17 |
Decision Date | 1996-01-22 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00816020020542 | K953354 | 000 |
00816020020535 | K953354 | 000 |
00816020020528 | K953354 | 000 |
00816020020511 | K953354 | 000 |
00816020020504 | K953354 | 000 |
00816020020498 | K953354 | 000 |