BZ-576 NON-INVASIVE AUTOMATIC BLOOD PRESSURE MONITOR
FDA 510(k) clearance K033216 · decided 2004-05-04
Clearance details
- K-number
- K033216
- Device name
- BZ-576 NON-INVASIVE AUTOMATIC BLOOD PRESSURE MONITOR
- Applicant
- The Buzz Group, LLC
- Decision
- Substantially Equivalent
- Date received
- 2003-10-03
- Decision date
- 2004-05-04
- Days to decision
- 214 days
- Clearance type
- Abbreviated
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Deer Field, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.