Fetal Doppler, Model FD88
FDA 510(k) clearance K182710 · decided 2019-03-01
Clearance details
- K-number
- K182710
- Device name
- Fetal Doppler, Model FD88
- Applicant
- Shenzzhen Luckcome Technology Inc., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2018-09-27
- Decision date
- 2019-03-01
- Days to decision
- 155 days
- Clearance type
- Traditional
- Product code
- KNG
- Device class
- 2
- Regulation number
- 884.2660
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Shenzzhen Luckcome Technology Inc.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.