Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)— 510(k) K220245
Substantially EquivalentContec Medical Systems Co.,Ltd
FDA 510(k) clearance K220245 for Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL), Substantially Equivalent on 2022-09-28. Applicant: Contec Medical Systems Co.,Ltd. Device class: 2.
Clearance details
- Applicant
- Contec Medical Systems Co.,Ltd
- Product code
- Code KNG
- Device class
- Class 2
- Regulation
- 21 CFR 884.2660
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Qinhuangdao, CN
Recent devices under product code KNG
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- K201980 — Infrared Thermometer
- K171360 — CONTEC Electrocardiograph
Data sourced from openFDA. This site is unofficial and independent of the FDA.