RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO— 510(k) K001079

Substantially Equivalent

Arjo, Inc.

FDA 510(k) clearance K001079 for RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO, Substantially Equivalent on 2000-05-01. Applicant: Arjo, Inc..

Clearance details

Applicant: Arjo, Inc.
Product code: Code ILJ
Advisory panel: Physical Medicine
Date received: 2000-04-04
Decision date: 2000-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roselle, IL, US

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Adverse events under product code ILJ

product code ILJ

Death: 4
Total: 4

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.