1800 MONITORING ECG ELECTRODE AND 1870 DIAPHORETIC MONITORING ECG ELECTRODES— 510(k) K945836

Name: FDA 510(k) clearance K945836
Creator: U.S. Food and Drug Administration
Published: 1995-06-20

Substantially Equivalent

Conmed Andover Medical, Inc.

FDA 510(k) clearance K945836 for 1800 MONITORING ECG ELECTRODE AND 1870 DIAPHORETIC MONITORING ECG ELECTRODES, Substantially Equivalent on 1995-06-20. Applicant: Conmed Andover Medical, Inc.. Device class: 2.

Clearance details

Applicant: Conmed Andover Medical, Inc.
Product code: Code DRX
Device class: Class 2
Regulation: 21 CFR 870.2360
Advisory panel: Cardiovascular
Date received: 1994-11-29
Decision date: 1995-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Haverhill, MA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Conmed Andover Medical, Inc.

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K946273 — 1700 MONITORING ECG ELECTRODE1995-05-17
K944655 — ECG ELECTRODE1994-11-22
K944726 — 1710 MONITORING ECG ELECTRODE1994-11-22
K944849 — 2700 CLEARTRACE RADIOTRANSLUCENT MONITORING ECG ELECTROBE1994-10-17
K942718 — CLOTH TENS/BNES ELECTRODE1994-09-22

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.