V-Trust Model TD-2202 Portable ECG Recorder
FDA 510(k) K101569 · Taidoc Technology Corporation
510(k) numberK101569
Submission
- Device name
- V-Trust Model TD-2202 Portable ECG Recorder
- Applicant
- Taidoc Technology Corporation
Taipei County, TW - Received
- June 4, 2010
- Decision date
- March 1, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DPS – Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2340
- Specialty
- Cardiovascular
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| K240229 | Masimo W1DPS · Traditional | Masimo Corporation | 08/08/2024SE |
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Questions and answers
When was V-Trust Model TD-2202 Portable ECG Recorder cleared by the FDA?
V-Trust Model TD-2202 Portable ECG Recorder (K101569) received a 510(k) decision of Substantially Equivalent on March 1, 2011, 270 days after the submission was received.
What is the product code of K101569?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.