The following data is part of a premarket notification filed by Lead-lok, Inc. with the FDA for Bunny Electrode/stealth Electrode Pre Wired Eeg.
| Device ID | K911529 |
| 510k Number | K911529 |
| Device Name: | BUNNY ELECTRODE/STEALTH ELECTRODE PRE WIRED EEG |
| Classification | Electrode, Electrocardiograph |
| Applicant | LEAD-LOK, INC. 500 AIRPORT WAY Sandpoint, ID 83864 |
| Contact | James W Healy |
| Correspondent | James W Healy LEAD-LOK, INC. 500 AIRPORT WAY Sandpoint, ID 83864 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-04 |
| Decision Date | 1992-11-09 |