ROMIAPEX MODEL A-15— 510(k) K101054

Name: FDA 510(k) clearance K101054
Creator: U.S. Food and Drug Administration
Published: 2010-09-03

Substantially Equivalent

Romidan, Ltd.

FDA 510(k) clearance K101054 for ROMIAPEX MODEL A-15, Substantially Equivalent on 2010-09-03. Applicant: Romidan, Ltd.. Device class: Unclassified.

Clearance details

Applicant: Romidan, Ltd.
Product code: Code LQY
Device class: Unclassified
Advisory panel: Unknown
Date received: 2010-04-15
Decision date: 2010-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kiryat-Ono, IL

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LQY

product code LQY

Malfunction: 504
Total: 504

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.