NICAS(TM) ELECTRODE— 510(k) K972001

Name: FDA 510(k) clearance K972001
Creator: U.S. Food and Drug Administration
Published: 1997-07-08

Substantially Equivalent

Ni Medical

FDA 510(k) clearance K972001 for NICAS(TM) ELECTRODE, Substantially Equivalent on 1997-07-08. Applicant: Ni Medical. Device class: 2.

Clearance details

Applicant: Ni Medical
Product code: Code DRX
Device class: Class 2
Regulation: 21 CFR 870.2360
Advisory panel: Cardiovascular
Date received: 1997-05-30
Decision date: 1997-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

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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.