DMS-9000— 510(k) K960836

Substantially Equivalent

O.R. Solutions, Inc.

FDA 510(k) clearance K960836 for DMS-9000, Substantially Equivalent on 1996-09-12. Applicant: O.R. Solutions, Inc..

Clearance details

Applicant: O.R. Solutions, Inc.
Product code: Code LRJ
Advisory panel: General Hospital
Date received: 1996-02-29
Decision date: 1996-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chantilly, VA, US

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Adverse events under product code LRJ

product code LRJ

Injury: 958
Total: 958

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.