IMMERSION HYDROBATH— 510(k) K082951
Substantially EquivalentArjo Hospital Equipment AB
FDA 510(k) clearance K082951 for IMMERSION HYDROBATH, Substantially Equivalent on 2009-04-08. Applicant: Arjo Hospital Equipment AB. Device class: 2.
Clearance details
- Applicant
- Arjo Hospital Equipment AB
- Product code
- Code ILJ
- Device class
- Class 2
- Regulation
- 21 CFR 890.5100
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Roselle, IL, US
Recent devices under product code ILJ
view allAdverse events under product code ILJ
product code ILJ- Death
- 4
- Total
- 4
Source: openFDA MAUDE database, through . 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.