3M Red Dot Resting EKG Electrode, Catalog 2360
FDA 510(k) K974445 · 3M Healthcare
510(k) numberK974445
Submission
- Device name
- 3M Red Dot Resting EKG Electrode, Catalog 2360
- Applicant
- 3M Healthcare
St. Paul, MN, US - Received
- November 25, 1997
- Decision date
- July 26, 1998
- 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 Resting EKG Electrode, Catalog 2360 cleared by the FDA?
3M Red Dot Resting EKG Electrode, Catalog 2360 (K974445) received a 510(k) decision of Substantially Equivalent on July 26, 1998, 243 days after the submission was received.
What is the product code of K974445?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.