FDA 510(k) · S.L.P.
K112822: SLEEPSTRIP II (S.L.P. , Ltd.)
S.L.P. , Ltd. received FDA 510(k) K112822 for SLEEPSTRIP II, with a decision date of Dec 27, 2011 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K112822 |
|---|---|
| Pathway | 510(k) |
| Applicant | S.L.P. , Ltd. |
| Device name | SLEEPSTRIP II |
| Product code | MNR: Ventilatory Effort Recorder |
| Regulation (21 CFR) | 868.2375 |
| Device class | Class 2 |
| Date received | Sep 28, 2011 |
| Decision date | Dec 27, 2011 |
| 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 (if known):________ Device Name: SleepStrip 11 Indications for Use: The SleepStrip I1 is intended to measure apnealhyponea events during sleep for the purpose of prescreening patients for sleep apnea syndrome. The device is intended to be used by adult patients as prescribed by a physician in either home, hospital or facility use settings. Prescription Use '4AND/OR Over-The-Counter Use-__ (Part 21 C.E.R. 801 Subpart D) (Part 21 C.F.R. 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Divisioin SitO- Divisioikaf'nesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K 1232-Z? 7-1
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.
- K002135 SLEEPSTRIP DISPOSABLE APNEA SCREENER (Influent)
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.