1103 DIGITAL BLOOD PRESSURE MONITOR, MODEL LD 1103, 1133 DIGITAL BLOOD PRESSURE MONITOR, MODEL LD 1133
FDA 510(k) clearance K093359 · decided 2009-11-27
Clearance details
- K-number
- K093359
- Device name
- 1103 DIGITAL BLOOD PRESSURE MONITOR, MODEL LD 1103, 1133 DIGITAL BLOOD PRESSURE MONITOR, MODEL LD 1133
- Applicant
- Shanghai Little Doctor Co. Limited
- Decision
- Substantially Equivalent
- Date received
- 2009-10-28
- Decision date
- 2009-11-27
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Nantong, Jiangsu, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.