The following data is part of a premarket notification filed by The Electrode Store, Inc. with the FDA for Surface Electrode For Electroencephalography.
| Device ID | K022197 |
| 510k Number | K022197 |
| Device Name: | SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY |
| Classification | Electrode, Cutaneous |
| 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 | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-05 |
| Decision Date | 2002-08-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816022023381 | K022197 | 000 |
| 00816022021813 | K022197 | 000 |
| 00816022021288 | K022197 | 000 |
| 00816022021264 | K022197 | 000 |
| 00816022021257 | K022197 | 000 |
| 00816022021240 | K022197 | 000 |
| 00816022021127 | K022197 | 000 |
| 00816022020465 | K022197 | 000 |
| 00816022020434 | K022197 | 000 |
| 00816022020427 | K022197 | 000 |
| 00816022020380 | K022197 | 000 |
| 00816022020373 | K022197 | 000 |
| 00816022020366 | K022197 | 000 |
| 00816022020359 | K022197 | 000 |
| 00816022021820 | K022197 | 000 |
| 00816022022186 | K022197 | 000 |
| 00816022023176 | K022197 | 000 |
| 00816022022896 | K022197 | 000 |
| 00816022022568 | K022197 | 000 |
| 00816022022490 | K022197 | 000 |
| 00816022022445 | K022197 | 000 |
| 00816022022391 | K022197 | 000 |
| 00816022022360 | K022197 | 000 |
| 00816022022346 | K022197 | 000 |
| 00816022022308 | K022197 | 000 |
| 00816022022292 | K022197 | 000 |
| 00816022022285 | K022197 | 000 |
| 00816022022261 | K022197 | 000 |
| 00816022022223 | K022197 | 000 |
| 00816022020342 | K022197 | 000 |