VITAL SIGNS MONITOR
FDA 510(k) clearance K131818 · decided 2013-08-30
Clearance details
- K-number
- K131818
- Device name
- VITAL SIGNS MONITOR
- Applicant
- Edan Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-06-20
- Decision date
- 2013-08-30
- Days to decision
- 71 days
- Clearance type
- Special
- Product code
- DQA
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Shenzhen, Guangdong, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Descri recall (Z-1142-2026) | Edan Diagnostics | 2026-01-22 |
| Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3A Product Descr recall (Z-1153-2026) | Edan Diagnostics | 2026-01-22 |