OXICARE FINGERTIP PULSE OXIMETER— 510(k) K133090
Substantially EquivalentDelbio Incorporation
FDA 510(k) clearance K133090 for OXICARE FINGERTIP PULSE OXIMETER, Substantially Equivalent on 2014-02-28. Applicant: Delbio Incorporation. Device class: 2.
Clearance details
- Applicant
- Delbio Incorporation
- Product code
- Code DQA
- Device class
- Class 2
- Regulation
- 21 CFR 870.2700
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Fremont City, CA, US
Recent devices under product code DQA
view all- K252821 — Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)
- K252655 — Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)
- K253887 — Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)
- K260931 — Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)
- K252448 — AViTA Pulse Oximeter (SP61)
More clearances from Delbio Incorporation
view all- K132338 — DA01 BLOOD GLUCOSE MONITORING SYSTEM
- K130244 — DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM
- K120866 — DA01 BLOOD GLUCOSE MONITORING SYSTEM
- K103329 — DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION
- K113343 — DIACHECK SMART/SUPERIOR BLOOD GLUCOSE MONITORING SYSTEM
Adverse events under product code DQA
product code DQA- Death
- 66
- Malfunction
- 2,867
- Other
- 1
- Total
- 2,934
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.