FDA 510(k) clearance · back to tracker

Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C)

Contec Medical Systems Co.,Ltd cleared K232908 on 2024-05-02, decision: substantially equivalent

K-number

K232908

Sponsor

Contec Medical Systems Co.,Ltd

Device

Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C)

Class

Class II

Decision

Substantially Equivalent

Decision date

2024-05-02

Product code

IYN

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.1550

Official FDA record

Open K232908on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.