Radio Transparent ECG Electrode
FDA 510(k) K761249 · Concept, Inc.
510(k) numberK761249
Submission
- Device name
- Radio Transparent ECG Electrode
- Applicant
- Concept, Inc.
Mchenry, IL, US - Received
- December 13, 1976
- Decision date
- December 21, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Radio Transparent ECG Electrode cleared by the FDA?
Radio Transparent ECG Electrode (K761249) received a 510(k) decision of Substantially Equivalent on December 21, 1976, 8 days after the submission was received.
What is the product code of K761249?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.