3M Red Dot ECG Lead Wires a
FDA 510(k) K954900 · Minnesota Mining and Mfg. Co.
510(k) numberK954900
Submission
- Device name
- 3M Red Dot ECG Lead Wires a
- Applicant
- Minnesota Mining and Mfg. Co.
St. Paul, MN, US - Received
- October 25, 1995
- Decision date
- July 15, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSA – Cable, Transducer And Electrode, Patient, (Including Connector)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2900
- Specialty
- Cardiovascular
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| K222712 | Fogg System Patient Monitoring CablesDSA · Traditional | Fogg System Company, Inc. | 11/22/2023SE |
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Questions and answers
When was 3M Red Dot ECG Lead Wires a cleared by the FDA?
3M Red Dot ECG Lead Wires a (K954900) received a 510(k) decision of Substantially Equivalent on July 15, 1996, 264 days after the submission was received.
What is the product code of K954900?
The FDA product code is DSA – Cable, Transducer And Electrode, Patient, (Including Connector), a Class II (moderate risk) device regulated under 21 CFR 870.2900.