The following data is part of a premarket notification filed by Inomed Medizintechnik Gmbh with the FDA for Isis Mer System/elekta Mer System.
| Device ID | K042208 |
| 510k Number | K042208 |
| Device Name: | ISIS MER SYSTEM/ELEKTA MER SYSTEM |
| Classification | Electrode, Depth |
| Applicant | INOMED MEDIZINTECHNIK GMBH KUNGSTENSGATAN 18, PO BX 7593 Stockholm, DE Se-103 93 |
| Contact | Anders Skoglund |
| Correspondent | Anders Skoglund INOMED MEDIZINTECHNIK GMBH KUNGSTENSGATAN 18, PO BX 7593 Stockholm, DE Se-103 93 |
| Product Code | GZL |
| CFR Regulation Number | 882.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-16 |
| Decision Date | 2005-03-18 |
| Summary: | summary |