Cleared Traditional

Ultrasonic Fetal Doppler

K233823 · Shenzhen Jamr Technology Co., Ltd. · Obstetrics & Gynecology
Jun 2024
Decision
210d
Days
Class 2
Risk

About This 510(k) Submission

K233823 is an FDA 510(k) clearance for the Ultrasonic Fetal Doppler, a Monitor, Ultrasonic, Fetal (Class II — Special Controls, product code KNG), submitted by Shenzhen Jamr Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 28, 2024, 210 days after receiving the submission on December 1, 2023. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.2660.

Submission Details

510(k) Number K233823 FDA.gov
FDA Decision Cleared SESE
Date Received December 01, 2023
Decision Date June 28, 2024
Days to Decision 210 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement

Device Classification

Product Code KNG — Monitor, Ultrasonic, Fetal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.2660

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