INTCO TAB ELECTRODE
FDA 510(k) clearance K093327 · decided 2010-05-10
Clearance details
- K-number
- K093327
- Device name
- INTCO TAB ELECTRODE
- Applicant
- Shanghai Intco Electrode Manufacturing Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2009-10-26
- Decision date
- 2010-05-10
- Days to decision
- 196 days
- Clearance type
- Abbreviated
- Product code
- DRX
- Device class
- 2
- Regulation number
- 870.2360
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Sandpoint, ID, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.