DeviceClearance

BIOCONNECT PATIENT MONITORING CABLES AND LEADWIRES, CAT# 1000 THRU CAT# 40000— 510(k) K010809

Substantially Equivalent

Rf Industries, Ltd.

FDA 510(k) clearance K010809 for BIOCONNECT PATIENT MONITORING CABLES AND LEADWIRES, CAT# 1000 THRU CAT# 40000, Substantially Equivalent on 2001-05-23. Applicant: Rf Industries, Ltd.. Device class: 2.

Clearance details

Applicant
Rf Industries, Ltd.
Product code
Product 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
Lake Elsinore, CA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code DSA

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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.