FETAL MONITORS, MODELS F2 AND F3
FDA 510(k) clearance K102140 · decided 2011-01-13
Clearance details
- K-number
- K102140
- Device name
- FETAL MONITORS, MODELS F2 AND F3
- Applicant
- Edan Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-07-29
- Decision date
- 2011-01-13
- Days to decision
- 168 days
- Clearance type
- Traditional
- Product code
- HGM
- Device class
- 2
- Regulation number
- 884.2740
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- 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: Fetal Monitor Model/Catalog Number: F2, F3 Product Descript recall (Z-1140-2026) | Edan Diagnostics | 2026-01-22 |