FDA 510(k) · Masimo
K033349: AC-1 SP02 ADAPTOR CABLE, MODEL AC-1 (Masimo Corp.)
Masimo Corp. received FDA 510(k) K033349 for AC-1 SP02 ADAPTOR CABLE, MODEL AC-1, with a decision date of Jan 28, 2004 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K033349 |
|---|---|
| Pathway | 510(k) |
| Applicant | Masimo Corp. |
| Device name | AC-1 SP02 ADAPTOR CABLE, MODEL AC-1 |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Oct 20, 2003 |
| Decision date | Jan 28, 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): K033349 Device Name: AC-I Adapter Cable Indications For Use: The AC-I Adapter Cable with Masimo sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO 2) and pulse rate (measured by an SpO 2 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 ANOTIHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (~Diision Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 6 4 00.'7 510(k) Number:
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.