The following data is part of a premarket notification filed by Inomed Gmbh with the FDA for Micro-recording And Stimulation Electrodes-micro Macroelectrode Model No. 230700-230799.
| Device ID | K041409 |
| 510k Number | K041409 |
| Device Name: | MICRO-RECORDING AND STIMULATION ELECTRODES-MICRO MACROELECTRODE MODEL NO. 230700-230799 |
| Classification | Electrode, Depth |
| Applicant | INOMED GMBH KUNGSTENSGATAN 18, PO BX 7593 Se-103 93 Stockholm, SE |
| Contact | Anders Skoglund |
| Correspondent | Anders Skoglund INOMED GMBH KUNGSTENSGATAN 18, PO BX 7593 Se-103 93 Stockholm, SE |
| Product Code | GZL |
| CFR Regulation Number | 882.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-27 |
| Decision Date | 2004-08-20 |
| Summary: | summary |