Dynamic ECG System Model TLC5000
FDA 510(k) K101273 · Contec Medical System Co., Ltd.
510(k) numberK101273
Submission
- Device name
- Dynamic ECG System Model TLC5000
- Applicant
- Contec Medical System Co., Ltd.
Shanghai, CN - Received
- May 6, 2010
- Decision date
- September 30, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MLO – Electrocardiograph, Ambulatory, With Analysis Algorithm
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2800
- Specialty
- Cardiovascular
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Questions and answers
When was Dynamic ECG System Model TLC5000 cleared by the FDA?
Dynamic ECG System Model TLC5000 (K101273) received a 510(k) decision of Substantially Equivalent on September 30, 2011, 512 days after the submission was received.
What is the product code of K101273?
The FDA product code is MLO – Electrocardiograph, Ambulatory, With Analysis Algorithm, a Class II (moderate risk) device regulated under 21 CFR 870.2800.