Red Dot Monitoring Electrodes #2260/65
FDA 510(k) K821438 · 3M Company
510(k) numberK821438
Submission
- Device name
- Red Dot Monitoring Electrodes #2260/65
- Applicant
- 3M Company
White City, OR, US - Received
- May 13, 1982
- Decision date
- May 25, 1982
- 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 Red Dot Monitoring Electrodes #2260/65 cleared by the FDA?
Red Dot Monitoring Electrodes #2260/65 (K821438) received a 510(k) decision of Substantially Equivalent on May 25, 1982, 12 days after the submission was received.
What is the product code of K821438?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.