The following data is part of a premarket notification filed by Somatics, Inc. with the FDA for Disposable Eeg/ekg Electrode, Cat. #eeds.
| Device ID | K890710 |
| 510k Number | K890710 |
| Device Name: | DISPOSABLE EEG/EKG ELECTRODE, CAT. #EEDS |
| Classification | Electrode, Cutaneous |
| Applicant | SOMATICS, INC. 910 SHERWOOD DR., UNIT 17 Lake Bluff, IL 60044 |
| Contact | Abrams, M.d. |
| Correspondent | Abrams, M.d. SOMATICS, INC. 910 SHERWOOD DR., UNIT 17 Lake Bluff, IL 60044 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-13 |
| Decision Date | 1989-03-14 |