The following data is part of a premarket notification filed by Ambu, Inc. with the FDA for Ambu Neuroline Single Patient Eeg/ep Cup Electrode.
| Device ID | K032278 |
| 510k Number | K032278 |
| Device Name: | AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE |
| Classification | Electrode, Cutaneous |
| Applicant | AMBU, INC. 611 NORTH HAMMONDS FERRY RD. Linthicum, MD 21090 -1356 |
| Contact | Sanjay Parikh |
| Correspondent | Sanjay Parikh AMBU, INC. 611 NORTH HAMMONDS FERRY RD. Linthicum, MD 21090 -1356 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-24 |
| Decision Date | 2004-03-05 |