LDS Monitoring Electrode
FDA 510(k) K821846 · Life Design Systems, Inc.
510(k) numberK821846
Submission
- Device name
- LDS Monitoring Electrode
- Applicant
- Life Design Systems, Inc.
Mchenry, IL, US - Received
- June 22, 1982
- Decision date
- July 30, 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 LDS Monitoring Electrode cleared by the FDA?
LDS Monitoring Electrode (K821846) received a 510(k) decision of Substantially Equivalent on July 30, 1982, 38 days after the submission was received.
What is the product code of K821846?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.