NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM
FDA 510(k) clearance K002791 · decided 2001-01-29
Clearance details
- K-number
- K002791
- Device name
- NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM
- Applicant
- Unix Electronic Co. , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2000-09-07
- Decision date
- 2001-01-29
- Days to decision
- 144 days
- Clearance type
- Traditional
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Bonita Springs, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.