INTEGRATED INNOVA - S5I SYSTEM OPTION
FDA 510(k) clearance K111209 · decided 2011-07-26
Clearance details
- K-number
- K111209
- Device name
- INTEGRATED INNOVA - S5I SYSTEM OPTION
- Applicant
- GE Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2011-04-29
- Decision date
- 2011-07-26
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- IZI
- Device class
- 2
- Regulation number
- 892.1600
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Buc, FR
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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