The following data is part of a premarket notification filed by Compumedics Limited with the FDA for Compumedics Somte Psg Recording System.
| Device ID | K072201 |
| 510k Number | K072201 |
| Device Name: | COMPUMEDICS SOMTE PSG RECORDING SYSTEM |
| Classification | Ventilatory Effort Recorder |
| Applicant | COMPUMEDICS LIMITED 30-40 FLOCKHART STREET ABBOTSFORD Melbourne, Victoria, AU 3067 |
| Contact | Gordon Ferguson |
| Correspondent | Gordon Ferguson COMPUMEDICS LIMITED 30-40 FLOCKHART STREET ABBOTSFORD Melbourne, Victoria, AU 3067 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-08 |
| Decision Date | 2008-04-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09342451001498 | K072201 | 000 |
| 09342451001481 | K072201 | 000 |
| 09342451001474 | K072201 | 000 |
| 09342451001467 | K072201 | 000 |
| 09342451001382 | K072201 | 000 |
| 09342451001368 | K072201 | 000 |