The following data is part of a premarket notification filed by Bio-logic Systems Corp. with the FDA for Disposable Cutaneous Electrodes.
| Device ID | K941799 |
| 510k Number | K941799 |
| Device Name: | DISPOSABLE CUTANEOUS ELECTRODES |
| Classification | Electrode, Cutaneous |
| Applicant | BIO-LOGIC SYSTEMS CORP. ONE BIO-LOGIC PLAZA Mundelein, IL 60060 -3700 |
| Contact | Ron Rolfsen |
| Correspondent | Ron Rolfsen BIO-LOGIC SYSTEMS CORP. ONE BIO-LOGIC PLAZA Mundelein, IL 60060 -3700 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-12 |
| Decision Date | 1995-02-03 |