The following data is part of a premarket notification filed by Mt Monitortechnik Gmbh & Co. Kg with the FDA for Narcotrend, Model Compact 4.0.
| Device ID | K033543 |
| 510k Number | K033543 |
| Device Name: | NARCOTREND, MODEL COMPACT 4.0 |
| Classification | Index-generating Electroencephalograph Software |
| Applicant | MT MONITORTECHNIK GMBH & CO. KG MAIENBAS 27 Bad Bramstedt, DE D-24576 |
| Contact | Friedmund Wieland |
| Correspondent | Friedmund Wieland MT MONITORTECHNIK GMBH & CO. KG MAIENBAS 27 Bad Bramstedt, DE D-24576 |
| Product Code | OLW |
| Subsequent Product Code | OLT |
| Subsequent Product Code | OMC |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-10 |
| Decision Date | 2004-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260497025016 | K033543 | 000 |
| 04260497025009 | K033543 | 000 |
| 04260497021063 | K033543 | 000 |