3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE— 510(k) K934333

Substantially Equivalent

3M Medical Products Group

FDA 510(k) clearance K934333 for 3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE, Substantially Equivalent on 1994-07-07. Applicant: 3M Medical Products Group.

Clearance details

Applicant: 3M Medical Products Group
Product code: Code DRX
Advisory panel: Cardiovascular
Date received: 1993-09-07
Decision date: 1994-07-07
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.