CARDIOSTATION-100 (CS-100)
FDA 510(k) clearance K041031 · decided 2005-01-26
Clearance details
- K-number
- K041031
- Device name
- CARDIOSTATION-100 (CS-100)
- Applicant
- Us Clover Co.
- Decision
- Substantially Equivalent
- Date received
- 2004-04-21
- Decision date
- 2005-01-26
- Days to decision
- 280 days
- Clearance type
- Traditional
- Product code
- DQK
- Device class
- 2
- Regulation number
- 870.1425
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- City Of Industry, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.