FDA 510(k) · Masimo
K993555: MASIMO SET/QUARTZ 2500 PULSE OXIMETER AND ACCESSORIES (Masimo Corp.)
Masimo Corp. received FDA 510(k) K993555 for MASIMO SET/QUARTZ 2500 PULSE OXIMETER AND ACCESSORIES, with a decision date of Nov 19, 1999 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K993555 |
|---|---|
| Pathway | 510(k) |
| Applicant | Masimo Corp. |
| Device name | MASIMO SET/QUARTZ 2500 PULSE OXIMETER AND ACCESSORIES |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Oct 20, 1999 |
| Decision date | Nov 19, 1999 |
| 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
We could not extract the indications for this record (no summary PDF was processed). Check the FDA record for its summary or statement.
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.