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

Name: FDA 510(k) clearance K971444
Creator: U.S. Food and Drug Administration
Published: 1997-06-11

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. Device class: 2.

Clearance details

Applicant: 3M Medical Products Group
Product code: Code DRX
Device class: Class 2
Regulation: 21 CFR 870.2360
Advisory panel: Cardiovascular
Date received: 1997-04-21
Decision date: 1997-06-11
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 Medical Products Group

view all

K955103 — 3M NO STING BARRIER FILM1996-02-05
K952121 — 3M RESIN CEMENT1995-06-22
K945726 — 3M(TM) EAR IMPRESSION MATERIAL1995-01-27
K941718 — 3M FLUID CONTROL SYSTEM 8300 CASSETTE LOAD1994-10-07
K934333 — 3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE1994-07-07

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.