The following data is part of a premarket notification filed by Ambu A/s with the FDA for Modification To: Ambu Neuroline Concentric Needle Electrode.
| Device ID | K071186 |
| 510k Number | K071186 |
| Device Name: | MODIFICATION TO: AMBU NEUROLINE CONCENTRIC 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-30 |
| Decision Date | 2007-07-30 |
| Summary: | summary |