EPIC SPO2 FINGER SENSOR, MODEL E412-20— 510(k) K002223
Substantially EquivalentEpic Medical Equipment Services, Inc.
FDA 510(k) clearance K002223 for EPIC SPO2 FINGER SENSOR, MODEL E412-20, Substantially Equivalent on 2000-08-22. Applicant: Epic Medical Equipment Services, Inc.. Device class: 2.
Clearance details
- Applicant
- Epic Medical Equipment Services, Inc.
- 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
- Plano, TX, US
Recent devices under product code DQA
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- 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 Epic Medical Equipment Services, Inc.
view allAdverse 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.