PATIENT MONITOR
FDA 510(k) clearance K113623 · decided 2012-02-01
Clearance details
- K-number
- K113623
- Device name
- PATIENT MONITOR
- Applicant
- Edan Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-12-05
- Decision date
- 2012-02-01
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, iM60, iM70, iM8 recall (Z-1145-2026) | Edan Diagnostics | 2026-01-22 |