Graphic Controls Biotac Eco Electrode
FDA 510(k) K950488 · Graphic Controls Corp.
510(k) numberK950488
Submission
- Device name
- Graphic Controls Biotac Eco Electrode
- Applicant
- Graphic Controls Corp.
Buffalo, NY, US - Received
- February 6, 1995
- Decision date
- July 3, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 Graphic Controls Biotac Eco Electrode cleared by the FDA?
Graphic Controls Biotac Eco Electrode (K950488) received a 510(k) decision of Substantially Equivalent on July 3, 1995, 147 days after the submission was received.
What is the product code of K950488?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.