KODEA, MODELS XJ-2001AC; XJ-2002AS; XJ-2003A
FDA 510(k) clearance K062893 · decided 2007-02-05
Clearance details
- K-number
- K062893
- Device name
- KODEA, MODELS XJ-2001AC; XJ-2002AS; XJ-2003A
- Applicant
- Shanghai Kodea Economic and Trade Development , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2006-09-27
- Decision date
- 2007-02-05
- Days to decision
- 131 days
- Clearance type
- Abbreviated
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Shanghai, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.