KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE CR 260
FDA 510(k) clearance K073670 · decided 2008-01-25
Clearance details
- K-number
- K073670
- Device name
- KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE CR 260
- Applicant
- Orex Computed Radiography, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2007-12-27
- Decision date
- 2008-01-25
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- MQB
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Yoqneam, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.