HAFCON (FLOURO FOOTSWITCH)— 510(k) K901671

Name: FDA 510(k) clearance K901671
Creator: U.S. Food and Drug Administration
Published: 1990-08-08

Substantially Equivalent

B & H Research Instruments

FDA 510(k) clearance K901671 for HAFCON (FLOURO FOOTSWITCH), Substantially Equivalent on 1990-08-08. Applicant: B & H Research Instruments. Device class: 2.

Clearance details

Applicant: B & H Research Instruments
Product code: Code JAA
Device class: Class 2
Regulation: 21 CFR 892.1650
Advisory panel: Radiology
Date received: 1990-04-10
Decision date: 1990-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shreveport, LA, US

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Adverse events under product code JAA

product code JAA

Other: 1
Total: 1

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.