The following data is part of a premarket notification filed by Compumedics Limited with the FDA for Compumedics Siesta System.
| Device ID | K003175 |
| 510k Number | K003175 |
| Device Name: | COMPUMEDICS SIESTA SYSTEM |
| Classification | Standard Polysomnograph With Electroencephalograph |
| Applicant | COMPUMEDICS LIMITED 6740 RIVERVIEW TERRACE Minneapolis,, MN 55432 |
| Contact | Constance Bundy |
| Correspondent | Constance Bundy COMPUMEDICS LIMITED 6740 RIVERVIEW TERRACE Minneapolis,, MN 55432 |
| Product Code | OLV |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-10 |
| Decision Date | 2000-12-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09342451001788 | K003175 | 000 |
| 09342451002112 | K003175 | 000 |