3M RED DOT 2234 & 2266 RADIOLUCENT MONITORING ELECTRODES— 510(k) K971444

Substantially Equivalent

3M Medical Products Group

FDA 510(k) clearance K971444 for 3M RED DOT 2234 & 2266 RADIOLUCENT MONITORING ELECTRODES, Substantially Equivalent on 1997-06-11. Applicant: 3M Medical Products Group.

Clearance details

Applicant: 3M Medical Products Group
Product code: Code DRX
Advisory panel: Cardiovascular
Date received: 1997-04-21
Decision date: 1997-06-11
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, 2020-01-01 through 2026-04-23. 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.