The following data is part of a premarket notification filed by Compumedics Ptd Ltd. with the FDA for Sleep System For Clinics & Research.
| Device ID | K955841 |
| 510k Number | K955841 |
| Device Name: | SLEEP SYSTEM FOR CLINICS & RESEARCH |
| Classification | Ventilatory Effort Recorder |
| Applicant | COMPUMEDICS PTD LTD. 3377 NORTH TORREY PINES CT. SUITE 100 La Jolla, CA 92037 |
| Contact | Steve Reitzler |
| Correspondent | Steve Reitzler COMPUMEDICS PTD LTD. 3377 NORTH TORREY PINES CT. SUITE 100 La Jolla, CA 92037 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-22 |
| Decision Date | 1997-03-11 |
| Summary: | summary |