KENZ CARDY302 MAX
FDA 510(k) clearance K101024 · decided 2011-01-06
Clearance details
- K-number
- K101024
- Device name
- KENZ CARDY302 MAX
- Applicant
- Suzuken Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2010-04-13
- Decision date
- 2011-01-06
- Days to decision
- 268 days
- Clearance type
- Traditional
- Product code
- MWJ
- Device class
- 2
- Regulation number
- 870.2800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Richardson, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.