3M RED DOT RADIOLUCENT MONITORING ELECTRODE WITH CONDUCTIVE ADHESIVE— 510(k) K000690
Substantially EquivalentMinnesota Mining and Mfg. Co.
FDA 510(k) clearance K000690 for 3M RED DOT RADIOLUCENT MONITORING ELECTRODE WITH CONDUCTIVE ADHESIVE, Substantially Equivalent on 2000-05-17. Applicant: Minnesota Mining and Mfg. Co.. Device class: 2.
Clearance details
- Applicant
- Minnesota Mining and Mfg. Co.
- Product code
- Code DRX
- Device class
- Class 2
- Regulation
- 21 CFR 870.2360
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Paul, MN, US
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Adverse events under product code DRX
product code DRX- Death
- 6
- Injury
- 476
- Other
- 2
- Total
- 484
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.