FDA 510(k) · Masimo
K042346: LNCS OXIMETRY SENSORS (Masimo Corporation)
Masimo Corporation received FDA 510(k) K042346 for LNCS OXIMETRY SENSORS, with a decision date of Sep 20, 2004 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K042346 |
|---|---|
| Pathway | 510(k) |
| Applicant | Masimo Corporation |
| Device name | LNCS OXIMETRY SENSORS |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Aug 30, 2004 |
| Decision date | Sep 20, 2004 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Special |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
510(k) Number (if known): Device Name: LNOPv and LNOP x Oximetry Sensors Indications For Use: The LNOPv and LNOP x Oximetry Sensors are indicated for the continuous noninvasive monitoring of functional 0 for use with adult, oxygen saturation of arterial hemoglobin (SpO 2) and pulse rate (measured by an SP 2 sensor) motion conditions, and for patients who are well or pediatric, infant, and neonatal patients during both no motion and poorly perfused in hospitals, hospital-type facilities, mobile, and home environments. _AND/OR Over-The-Counter Use . . 000 W Prescription Use XX _ (Per 21 CFR 801 Subpart D) (Per 21 CFR 807 Subpart C) IF NEEDED) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE Concurrence of CDRH, Oc of Device Evaluation (ODE) (Division Sign-Off) ,,j Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number : I&DLUN), 4-4
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.
- K033298 SPO2.COM OXIMETRY SENSORS, MULTIPLE MOD… (Masimo)
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 DQA is "Oximeter", class 2, 21 CFR 870.2700.
Our labels for filtering: claim SpO2 / pulse oximetry, sensor Finger PPG. These are heuristics, not FDA fields.