FDA 510(k) · Delbio
K122927: OXICARE FINGERTIP PULSE OXIMETER (Delbio Incorporated)
Delbio Incorporated received FDA 510(k) K122927 for OXICARE FINGERTIP PULSE OXIMETER, with a decision date of Dec 20, 2012 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K122927 |
|---|---|
| Pathway | 510(k) |
| Applicant | Delbio Incorporated |
| Device name | OXICARE FINGERTIP PULSE OXIMETER |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Sep 24, 2012 |
| Decision date | Dec 20, 2012 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
Form 51 0(k) Number (ifknown): 1j< flZ.ZC Device Name: Oxicare Fingertip Pulse Oxirneter, model DBI1 Indications for Use: The OxiCare Fingertip Pulse Oximeter, model DB1 1 is indicated for spot-checking of functional arterial oxygen saturation (SpO2) and pulse rate (PR) of adult and pediatric patients in hospitals, physician's office, clinical settings and home care environment. The OxiCare Fingertip Pulse Oximeter, model 0811 is not intended for continuous monitoring. Prescription Use X AN/R Over-The-Counter Use ___ (Part 21 CFR 801 Subpart D) (21 CFRt 801 Subpart C) (PLEASE DO NOT WRITE BELOW TIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of,Device Evaluation (ODE) Albert E.Moyal Albert E.Moyal1 2012212.19 12:05:46 -05'00' for LS (Divison Ilgu-OMf
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.