EUSEK-BUSH IN-BATH FILMING DEVICE (#MC-00186)— 510(k) K870429

Name: FDA 510(k) clearance K870429
Creator: U.S. Food and Drug Administration
Published: 1987-02-11

Substantially Equivalent

The Mason Clinic

FDA 510(k) clearance K870429 for EUSEK-BUSH IN-BATH FILMING DEVICE (#MC-00186), Substantially Equivalent on 1987-02-11. Applicant: The Mason Clinic. Device class: 2.

Clearance details

Applicant: The Mason Clinic
Product code: Code JAA
Device class: Class 2
Regulation: 21 CFR 892.1650
Advisory panel: Radiology
Date received: 1987-02-05
Decision date: 1987-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

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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.