FDA 510(k) · Compumedics
K955841: SLEEP SYSTEM FOR CLINICS & RESEARCH (Compumedics Ptd , Ltd.)
Compumedics Ptd , Ltd. received FDA 510(k) K955841 for SLEEP SYSTEM FOR CLINICS & RESEARCH, with a decision date of Mar 11, 1997.
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K955841 |
|---|---|
| Pathway | 510(k) |
| Applicant | Compumedics Ptd , Ltd. |
| Device name | SLEEP SYSTEM FOR CLINICS & RESEARCH |
| Product code | MNR: Ventilatory Effort Recorder |
| Regulation (21 CFR) | 868.2375 |
| Device class | Class 2 |
| Date received | Dec 22, 1995 |
| Decision date | Mar 11, 1997 |
| Decision | Unknown (SESK) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
We could not extract the indications for this record (no summary PDF was processed). Check the FDA record for its summary or statement.
Predicates parsed from FDA documents
No predicate numbers were parsed for this record. The FDA summary, if available, names the predicate.
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code MNR is "Ventilatory Effort Recorder", class 2, 21 CFR 868.2375.
Our labels for filtering: claim Sleep apnea, sensor Other. These are heuristics, not FDA fields.