FDA 510(k) · Masimo
K050068: LNOPV AD-L AND PD-L OXIMETRY SENSORS (Masimo Corporation)
Masimo Corporation received FDA 510(k) K050068 for LNOPV AD-L AND PD-L OXIMETRY SENSORS, with a decision date of Feb 9, 2005 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K050068 |
|---|---|
| Pathway | 510(k) |
| Applicant | Masimo Corporation |
| Device name | LNOPV AD-L AND PD-L OXIMETRY SENSORS |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Jan 12, 2005 |
| Decision date | Feb 9, 2005 |
| 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 Ad-L and Pd-L Oximetry Sensors Indications For Use: monitoring of functional The LNOPv Ad-L and Pd-L Oximetry Sensors are indicated for the continuous noninvasive sensor) for use with adult and oxygen saturation of arterial hemoglobin (SpO 2) and pulse rate (measured by an SpO2 are well or poorly perfused in pediatric patients during both no motion and motion conditions, and for patients who hospitals, hospital-type facilities, mobile, and home environments. Prescription Use ___X_ AND/OR Over-The-Counter Use (Per 21 CFR 801 Subpart D) (Per 21 CFR 807 Subpart C) 00 .C PAGE IF NEEDED) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER Concurrence of CDRH, Office of Device Evaluation (ODE) At!3hesiology, General , tcoL Dental Devices ghr0 5 oofoS
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
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 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.