CORROSION PROOF SNAP ECG CONNECT WIRES— 510(k) K802236

Substantially Equivalent

Custom Cardio Components

FDA 510(k) clearance K802236 for CORROSION PROOF SNAP ECG CONNECT WIRES, Substantially Equivalent on 1980-10-03. Applicant: Custom Cardio Components. Device class: 2.

Clearance details

Applicant
Custom Cardio Components
Product code
Code DSA
Device class
Class 2
Regulation
21 CFR 870.2900
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code DSA

product code DSA
Death
2
Total
2

Source: openFDA MAUDE database, through . 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.