CYCLETRAC CT-5000
FDA 510(k) clearance K073542 · decided 2008-02-14
Clearance details
- K-number
- K073542
- Device name
- CYCLETRAC CT-5000
- Applicant
- Pt Products, LLC
- Decision
- Substantially Equivalent
- Date received
- 2007-12-17
- Decision date
- 2008-02-14
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- ITH
- Device class
- 2
- Regulation number
- 890.5900
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Farmington Hills, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GE OEC 9900 Elite ESP fluoroscopic x-ray system. GE Healthcare, Surgery, Salt Lake City, U recall (Z-0341-2009) | OEC Medical Systems, Inc | 2009-01-05 |
| GE OEC 9900 Elite GSP fluoroscopic x-ray system GE Healthcare, Surgery, Salt Lake City, UT recall (Z-0342-2009) | OEC Medical Systems, Inc | 2009-01-05 |