The following data is part of a premarket notification filed by Compumedics Limited with the FDA for Compumedics Somte System.
| Device ID | K021176 |
| 510k Number | K021176 |
| Device Name: | COMPUMEDICS SOMTE SYSTEM |
| Classification | Ventilatory Effort Recorder |
| Applicant | COMPUMEDICS LIMITED 6740 RIVERVIEW TERRACE Minneapolis,, MN 55432 |
| Contact | Constance G Bundy |
| Correspondent | Constance G Bundy COMPUMEDICS LIMITED 6740 RIVERVIEW TERRACE Minneapolis,, MN 55432 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-12 |
| Decision Date | 2003-01-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09342451001764 | K021176 | 000 |
| 09342451001757 | K021176 | 000 |
| 09342451001740 | K021176 | 000 |
| 09342451001733 | K021176 | 000 |