A&D Medical Blood Pressure Monitors
FDA 510(k) clearance K173191 · decided 2019-03-21
Clearance details
- K-number
- K173191
- Device name
- A&D Medical Blood Pressure Monitors
- Applicant
- A&D Company, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2017-10-02
- Decision date
- 2019-03-21
- Days to decision
- 535 days
- Clearance type
- Traditional
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.