FDA 510(k) · Masimo
K033298: SPO2.COM OXIMETRY SENSORS, MULTIPLE MODELS (Masimo Corp.)
Masimo Corp. received FDA 510(k) K033298 for SPO2.COM OXIMETRY SENSORS, MULTIPLE MODELS, with a decision date of Dec 12, 2003 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K033298 |
|---|---|
| Pathway | 510(k) |
| Applicant | Masimo Corp. |
| Device name | SPO2.COM OXIMETRY SENSORS, MULTIPLE MODELS |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Oct 14, 2003 |
| Decision date | Dec 12, 2003 |
| 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): K033298 Device Name: SPO2.COM Sensors and Cables Indications For Use: The SPO2.COM Sensors and Cables are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO 2) and pulse rate (measured by an SPO2 sensor) for use with adult, pediatric, infant, and neonatal patients in 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) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) QJivision Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number: K (03,S2 8
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.
Later records that cite K033298
- K042346 LNCS OXIMETRY SENSORS (Masimo, Sep 20, 2004, DQA)
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.