DOLOMITE ROLLATOR— 510(k) K921917

Substantially Equivalent

Seamark Technologies

FDA 510(k) clearance K921917 for DOLOMITE ROLLATOR, Substantially Equivalent on 1992-05-26. Applicant: Seamark Technologies.

Clearance details

Applicant: Seamark Technologies
Product code: Code INM
Advisory panel: Physical Medicine
Date received: 1992-04-23
Decision date: 1992-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boca Raton, FL, US

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Adverse events under product code INM

product code INM

Death: 3
Total: 3

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.