MARCH HEALTHCARE HEALTH MONITORING KIT
FDA 510(k) clearance K060194 · decided 2006-02-13
Clearance details
- K-number
- K060194
- Device name
- MARCH HEALTHCARE HEALTH MONITORING KIT
- Applicant
- March Healthcare Corporation
- Decision
- Substantially Equivalent
- Date received
- 2006-01-25
- Decision date
- 2006-02-13
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Ottawa, Ontario, CA
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.