The following data is part of a premarket notification filed by Ives Eeg Solutions, Inc. with the FDA for Pediatric Subdermal Wire Electrode (pswe).
| Device ID | K060189 |
| 510k Number | K060189 |
| Device Name: | PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE) |
| Classification | Electrode, Needle |
| Applicant | IVES EEG SOLUTIONS, INC. 6325 RIDEAU VALLEY DRIVE Manotick, Ontario, CA K4m 1b3 |
| Contact | John Ives |
| Correspondent | John Ives IVES EEG SOLUTIONS, INC. 6325 RIDEAU VALLEY DRIVE Manotick, Ontario, CA K4m 1b3 |
| Product Code | GXZ |
| CFR Regulation Number | 882.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-24 |
| Decision Date | 2006-05-30 |