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510(k) K182710

Fetal Doppler, Model FD88 by Shenzzhen Luckcome Technology Inc., Ltd. — Product Code KNG

K182710 is an FDA 510(k) premarket notification submitted by Shenzzhen Luckcome Technology Inc., Ltd. for the device "Fetal Doppler, Model FD88". The FDA issued a decision of Substantially Equivalent on March 1, 2019. The device falls under product code KNG (Monitor, Ultrasonic, Fetal), a Class II device regulated under 21 CFR 884.2660.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2019
Date Received
September 27, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Ultrasonic, Fetal
Device Class
Class II
Regulation Number
884.2660
Review Panel
OB
Submission Type

Other clearances for product code KNG

  • K252669 — Fetal Doppler U8-25, U9-25 (January 8, 2026)
  • K242846 — Doppler FHR Detector (BF-500D+, BF-560) (June 26, 2025)
  • K233823 — Ultrasonic Fetal Doppler (June 28, 2024)
  • K232893 — Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fet (June 14, 2024)
  • K220245 — Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) (September 28, 2022)
  • K211940 — Fetal Doppler (January 7, 2022)
  • K212084 — Fetal Doppler (November 3, 2021)
  • K191110 — HeraBEAT™ US (November 14, 2019)
  • K182526 — Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD- (May 29, 2019)
  • K182190 — Fetal Doppler (December 19, 2018)

FDA data resources