RIC CONFORMAL SOURCE, MODEL 100
FDA 510(k) clearance K090321 · decided 2009-05-27
Clearance details
- K-number
- K090321
- Device name
- RIC CONFORMAL SOURCE, MODEL 100
- Applicant
- Ri Consultants, LLC
- Decision
- Substantially Equivalent
- Date received
- 2009-02-09
- Decision date
- 2009-05-27
- Days to decision
- 107 days
- Clearance type
- Traditional
- Product code
- ONL
- Device class
- 2
- Regulation number
- 892.5730
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Hudson, NH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.