The following data is part of a premarket notification filed by Medelec, Inc. D.b.a. Teca Corp. with the FDA for Teca Ncs Electrode System 2000.
| Device ID | K971914 |
| 510k Number | K971914 |
| Device Name: | TECA NCS ELECTRODE SYSTEM 2000 |
| Classification | Electrode, Cutaneous |
| Applicant | MEDELEC, INC. D.B.A. TECA CORP. 3 CAMPUS DR. Pleasantville, NY 10570 |
| Contact | James P Hurlman |
| Correspondent | James P Hurlman MEDELEC, INC. D.B.A. TECA CORP. 3 CAMPUS DR. Pleasantville, NY 10570 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-23 |
| Decision Date | 1998-03-26 |