3M Red Dot Radiolucent Monitoring Electrode with Conductive Adhesive
FDA 510(k) K000690 · Minnesota Mining and Mfg. Co.
510(k) numberK000690
Submission
- Device name
- 3M Red Dot Radiolucent Monitoring Electrode with Conductive Adhesive
- Applicant
- Minnesota Mining and Mfg. Co.
St. Paul, MN, US - Received
- February 29, 2000
- Decision date
- May 17, 2000
- 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 3M Red Dot Radiolucent Monitoring Electrode with Conductive Adhesive cleared by the FDA?
3M Red Dot Radiolucent Monitoring Electrode with Conductive Adhesive (K000690) received a 510(k) decision of Substantially Equivalent on May 17, 2000, 78 days after the submission was received.
What is the product code of K000690?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.