CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, 2710, 1800, SERIES— 510(k) K091856

Name: FDA 510(k) clearance K091856
Creator: U.S. Food and Drug Administration
Published: 2009-08-07

Substantially Equivalent

Conmed Corporation

FDA 510(k) clearance K091856 for CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, 2710, 1800, SERIES, Substantially Equivalent on 2009-08-07. Applicant: Conmed Corporation. Device class: 2.

Clearance details

Applicant: Conmed Corporation
Product code: Code DRX
Device class: Class 2
Regulation: 21 CFR 870.2360
Advisory panel: Cardiovascular
Date received: 2009-06-23
Decision date: 2009-08-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Utica, NY, 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 Conmed Corporation

view all

K261363 — Y-Knotless Flex Anchors2026-05-13
K253763 — Y-Knotless Flex Anchors2026-01-29
K252946 — BioBrace® Extra-Articular Ligament Augmentation Kit2025-10-15
K251530 — CONMED Argo Knotless® Anchor2025-06-18
K250395 — BioBrace ® RC Delivery System2025-04-07

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.