Patient Monitor
FDA 510(k) clearance K202336 · decided 2021-01-23
Clearance details
- K-number
- K202336
- Device name
- Patient Monitor
- Applicant
- Edan Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-08-17
- Decision date
- 2021-01-23
- Days to decision
- 159 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 |