The following data is part of a premarket notification filed by Ambu A/s with the FDA for Ambu Neuroline Disposable Inoject Needle Electrode.
| Device ID | K093825 |
| 510k Number | K093825 |
| Device Name: | AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE |
| Classification | Electrode, Needle, Diagnostic Electromyograph |
| Applicant | AMBU A/S 6740 BAYMEADOW DR. Glen Burnie, MD 21060 |
| Contact | Sanjay Parikh |
| Correspondent | Sanjay Parikh AMBU A/S 6740 BAYMEADOW DR. Glen Burnie, MD 21060 |
| Product Code | IKT |
| CFR Regulation Number | 890.1385 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-14 |
| Decision Date | 2010-01-13 |
| Summary: | summary |