FDA 510(k) · Itamar
K010156: SLEEP PAT 200 DEVICE (Itamar Medical (C.M.) 1997 , Ltd.)
Itamar Medical (C.M.) 1997 , Ltd. received FDA 510(k) K010156 for SLEEP PAT 200 DEVICE, with a decision date of Jun 19, 2002 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K010156 |
|---|---|
| Pathway | 510(k) |
| Applicant | Itamar Medical (C.M.) 1997 , Ltd. |
| Device name | SLEEP PAT 200 DEVICE |
| Product code | MNR: Ventilatory Effort Recorder |
| Regulation (21 CFR) | 868.2375 |
| Device class | Class 2 |
| Date received | Jan 16, 2001 |
| Decision date | Jun 19, 2002 |
| Decision | Substantially Equivalent (SESE) |
| 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 because FDA's summary PDF was not available at the usual address. 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.