FDA 510(k) · S.L.P.
K042253: SLEEPSENSE SLEEP SENSORS (S.L.P. , Ltd.)
S.L.P. , Ltd. received FDA 510(k) K042253 for SLEEPSENSE SLEEP SENSORS, with a decision date of Oct 6, 2004 (substantially equivalent).
Prescription or OTC: Prescription (Rx) parsed from FDA documents (summary PDF: indications text (parsed))
FDA facts
| FDA number | K042253 |
|---|---|
| Pathway | 510(k) |
| Applicant | S.L.P. , Ltd. |
| Device name | SLEEPSENSE SLEEP SENSORS |
| Product code | MNR: Ventilatory Effort Recorder |
| Regulation (21 CFR) | 868.2375 |
| Device class | Class 2 |
| Date received | Aug 20, 2004 |
| Decision date | Oct 6, 2004 |
| 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
STATEMENT 510(k) Number: Device Name: SleepSense sensors for sleep disorder testing Indications for Use: SleepSense sleep sensors provide a qualitative measure of some physiological parameters for recording onto an FDA-cleared data acquisition system. Their target population: Children and adult patients who are screened during sleep disorder studies. Their environment of use is usually at a sleep laboratory or sometimes at the patient's home. (Division Sign-Of Division of Anesthesiology, General Hospital. Infection Control, Dental Devices 510(k Number: r-,04a s (PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED) 510(k) Number Prescription Use _ OR Over the Counter Use (Per 21 CFR 801.109) Section 8- Page 6
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary 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.