The following data is part of a premarket notification filed by World Precision Instruments, Inc. with the FDA for Dermtrode.
| Device ID | K883869 |
| 510k Number | K883869 |
| Device Name: | DERMTRODE |
| Classification | Tester, Electrode/lead, Electroencephalograph |
| Applicant | WORLD PRECISION INSTRUMENTS, INC. 375 QUINNIPIAC AVE. New Haven, CT 06513 |
| Contact | Jon L Phillips |
| Correspondent | Jon L Phillips WORLD PRECISION INSTRUMENTS, INC. 375 QUINNIPIAC AVE. New Haven, CT 06513 |
| Product Code | GYA |
| CFR Regulation Number | 882.1410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-13 |
| Decision Date | 1988-09-30 |