Fetal Doppler— 510(k) K142769

Substantially Equivalent

Icare Newlife Technologies, Inc.

FDA 510(k) clearance K142769 for Fetal Doppler, Substantially Equivalent on 2015-03-20. Applicant: Icare Newlife Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Icare Newlife Technologies, Inc.
Product code: Code HEK
Device class: Class 2
Regulation: 21 CFR 884.2660
Advisory panel: Obstetrics/Gynecology
Date received: 2014-09-25
Decision date: 2015-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code HEK

K060410 — ECHOHEART TRANSVAGINAL DOPPLER PROBE2006-04-10
K902190 — FETAL PULSE DETECTOR MODEL DOP-11990-10-22
K883334 — BIODOP(TM)1988-12-15
K771211 — DOPPLER (UTD-5 & UTD-6)1977-07-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.