HEALITE II SYSTEM— 510(k) K113668
Substantially EquivalentLutronic Corporation
FDA 510(k) clearance K113668 for HEALITE II SYSTEM, Substantially Equivalent on 2012-06-19. Applicant: Lutronic Corporation. Device class: 2.
Clearance details
- Applicant
- Lutronic Corporation
- Product code
- Code ILY
- Device class
- Class 2
- Regulation
- 21 CFR 890.5500
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Trevose, PA, US
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More clearances from Lutronic Corporation
view allAdverse events under product code ILY
product code ILY- Death
- 3
- Total
- 3
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.