TRULY AUTOMATIC ARM BLOOD PRESSURE MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63M
FDA 510(k) clearance K091434 · decided 2009-09-04
Clearance details
- K-number
- K091434
- Device name
- TRULY AUTOMATIC ARM BLOOD PRESSURE MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63M
- Applicant
- Truly Instrument Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2009-05-13
- Decision date
- 2009-09-04
- Days to decision
- 114 days
- Clearance type
- Abbreviated
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Shanwei Shi, Guang Dong, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.