FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168KB
FDA 510(k) clearance K092163 · decided 2009-11-16
Clearance details
- K-number
- K092163
- Device name
- FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168KB
- Applicant
- Health & Life Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2009-07-16
- Decision date
- 2009-11-16
- Days to decision
- 123 days
- Clearance type
- Traditional
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Chung Ho City, Taipei, Hsien, TW
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| XiO Radiation treatment Planning System, XiO Release 4.2.0 and above Usage: Used to create recall (Z-2578-2011) | Computerized Medical Systems Inc | 2011-06-16 |