RHAPSODY MRI— 510(k) K082126
Substantially EquivalentGrantadler Corporation
FDA 510(k) clearance K082126 for RHAPSODY MRI, Substantially Equivalent on 2008-11-13. Applicant: Grantadler Corporation. Device class: 2.
Clearance details
- Applicant
- Grantadler Corporation
- Product code
- Code LJT
- Device class
- Class 2
- Regulation
- 21 CFR 880.5965
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Appollo Beach, FL, US
Recent devices under product code LJT
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- K232737 — PowerPort ClearVUE Slim ECG Enabled Implantable Port +3 more
More clearances from Grantadler Corporation
view allAdverse events under product code LJT
product code LJT- Death
- 234
- Injury
- 6,468
- Malfunction
- 5,326
- Other
- 2
- Total
- 12,030
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.