3M RED DOT 2234 RADIOLUCENT MONITORING ELECTRODE— 510(k) K930312

Name: FDA 510(k) clearance K930312
Creator: U.S. Food and Drug Administration
Published: 1993-09-01

Substantially Equivalent

3M Health Care, Ltd.

FDA 510(k) clearance K930312 for 3M RED DOT 2234 RADIOLUCENT MONITORING ELECTRODE, Substantially Equivalent on 1993-09-01. Applicant: 3M Health Care, Ltd.. Device class: 2.

Clearance details

Applicant: 3M Health Care, Ltd.
Product code: Code DRX
Device class: Class 2
Regulation: 21 CFR 870.2360
Advisory panel: Cardiovascular
Date received: 1993-01-22
Decision date: 1993-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DRX

view all

K171244 — Physiotrace2017-08-23
K140096 — HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE2014-07-24
K123658 — BIOMODULE 3-M12013-04-24
K101576 — CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES2010-07-22
K101685 — IP-SET2010-07-01

More clearances from 3M Health Care, Ltd.

view all

K953904 — SARNS 9000 UNIVERSAL ROLLER PUMP1996-04-19
K926364 — ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129X1995-03-31
K941534 — MODULAR VS-22 CEMENTED FEMORAL HIP SYSTEM1995-03-06
K941748 — STERI-VAC GAS STERILIZER MODEL 8XL1994-12-02
K930681 — 3M PREVENTION FABRIC SURGICAL GOWN #78XX1994-02-10

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.