The following data is part of a premarket notification filed by The Electrode Store, Inc. with the FDA for Subdermal Needle Electrode For Electroencephalography, Models Pro-e12saf And Den-12saf.
| Device ID | K020910 |
| 510k Number | K020910 |
| Device Name: | SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF |
| Classification | Electrode, Needle |
| Applicant | THE ELECTRODE STORE, INC. 936-11TH AVENUE EAST Seattle, WA 98102 |
| Contact | Carl Youngmann |
| Correspondent | Carl Youngmann THE ELECTRODE STORE, INC. 936-11TH AVENUE EAST Seattle, WA 98102 |
| Product Code | GXZ |
| CFR Regulation Number | 882.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-20 |
| Decision Date | 2002-07-19 |