V-TRUST HANDHELD PULSE OXIMETER MODEL: TD-8201— 510(k) K101012
Substantially EquivalentTaidoc Technology Corporation
FDA 510(k) clearance K101012 for V-TRUST HANDHELD PULSE OXIMETER MODEL: TD-8201, Substantially Equivalent on 2010-12-15. Applicant: Taidoc Technology Corporation. Device class: 2.
Clearance details
- Applicant
- Taidoc Technology Corporation
- 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
- Traditional
- Location
- Taipei County, TW
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 Taidoc Technology Corporation
view all- K221349 — XPER Technology PREMIUM Pro Blood Glucose Monitoring System
- K201037 — FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System
- K200946 — Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241)
- K190579 — TD-4183 Blood Glucose Monitoring System
- K182934 — FORA P100 Blood Pressure 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.