Electrocardiograph (ECG) Electrode, Non-Sterile
FDA 510(k) K020003 · Bio Protech, Inc.
510(k) numberK020003
Submission
- Device name
- Electrocardiograph (ECG) Electrode, Non-Sterile
- Applicant
- Bio Protech, Inc.
Sparks, NV, US - Received
- January 2, 2002
- Decision date
- November 7, 2002
- 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 Electrocardiograph (ECG) Electrode, Non-Sterile cleared by the FDA?
Electrocardiograph (ECG) Electrode, Non-Sterile (K020003) received a 510(k) decision of Substantially Equivalent on November 7, 2002, 309 days after the submission was received.
What is the product code of K020003?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.