Disposal ECG Electrodes, Model Easyrode
FDA 510(k) K092389 · Suzuken Co., Ltd.
510(k) numberK092389
Submission
- Device name
- Disposal ECG Electrodes, Model Easyrode
- Applicant
- Suzuken Co., Ltd.
Tachikawa-Shi, Tokyo, JP - Received
- August 5, 2009
- Decision date
- October 13, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRX – Electrode, Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2360
- Specialty
- Cardiovascular
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Questions and answers
When was Disposal ECG Electrodes, Model Easyrode cleared by the FDA?
Disposal ECG Electrodes, Model Easyrode (K092389) received a 510(k) decision of Substantially Equivalent on October 13, 2009, 69 days after the submission was received.
What is the product code of K092389?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.