FETAL DOPPLER JPD-100S
FDA 510(k) clearance K110124 · decided 2011-02-04
Clearance details
- K-number
- K110124
- Device name
- FETAL DOPPLER JPD-100S
- Applicant
- Shenzhen Jumper Medical Equipment Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2011-01-18
- Decision date
- 2011-02-04
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- KNG
- Device class
- 2
- Regulation number
- 884.2660
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Shanghai, CN
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.