3M Red Dot 2234 Radiolucent Monitoring Electrode
FDA 510(k) K930312 · 3M Health Care, Ltd.
510(k) numberK930312
Submission
- Device name
- 3M Red Dot 2234 Radiolucent Monitoring Electrode
- Applicant
- 3M Health Care, Ltd.
St. Paul, MN, US - Received
- January 22, 1993
- Decision date
- September 1, 1993
- 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 2234 Radiolucent Monitoring Electrode cleared by the FDA?
3M Red Dot 2234 Radiolucent Monitoring Electrode (K930312) received a 510(k) decision of Substantially Equivalent on September 1, 1993, 222 days after the submission was received.
What is the product code of K930312?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.