Telectrode Wet Gel ECG Electrode
FDA 510(k) K083148 · Bio Protech, Inc.
510(k) numberK083148
Submission
- Device name
- Telectrode Wet Gel ECG Electrode
- Applicant
- Bio Protech, Inc.
Woonju-Si, Gangwon-Do, KR - Received
- October 24, 2008
- Decision date
- November 7, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 Telectrode Wet Gel ECG Electrode cleared by the FDA?
Telectrode Wet Gel ECG Electrode (K083148) received a 510(k) decision of Substantially Equivalent on November 7, 2008, 14 days after the submission was received.
What is the product code of K083148?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.