TBI STAND— 510(k) K972709
Substantially EquivalentMick Radio-Nuclear Instruments, Inc.
FDA 510(k) clearance K972709 for TBI STAND, Substantially Equivalent on 1997-10-16. Applicant: Mick Radio-Nuclear Instruments, Inc.. Device class: 2.
Clearance details
- Applicant
- Mick Radio-Nuclear Instruments, Inc.
- Product code
- Code IYE
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bronx, NY, US
Recent devices under product code IYE
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Adverse events under product code IYE
product code IYE- Malfunction
- 455
- Other
- 3
- Total
- 458
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.