FDA 510(k)

MD-320W Ultrasound Biomicroscope

K-Number: K213070 · 2021-11-18

Decision Date2021-11-18

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MD-320W Ultrasound Biomicroscope is a medical device manufactured by MEDA Co., Ltd.. It received FDA 510(k) clearance on 2021-11-18 under approval number K213070. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MD-320W Ultrasound Biomicroscope?

MD-320W Ultrasound Biomicroscope is a medical device that received FDA 510(k) clearance on 2021-11-18. It is manufactured by MEDA Co., Ltd.. The 510(k) number is K213070.

When was MD-320W Ultrasound Biomicroscope approved by the FDA?

MD-320W Ultrasound Biomicroscope received FDA 510(k) clearance on 2021-11-18, under approval number K213070.

What company makes MD-320W Ultrasound Biomicroscope?

MD-320W Ultrasound Biomicroscope is manufactured by MEDA Co., Ltd..

What is the FDA product code for MD-320W Ultrasound Biomicroscope?

The FDA product code for MD-320W Ultrasound Biomicroscope is IYO.

Other Devices by MEDA Co., Ltd.

K182460MD-6000P Bladder Scanner

Related Devices (Code: IYO)

K162972ExactVu High Resolution Micro-Ultrasound SystemExact Imaging K161968MicrUsTelemed K161342Sonic WindowAnalogic Corporation K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc. K153620Enovare Ultrasound SystemOreon Technologies, Inc. K160792Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder UltrasoundThe Prometheus Group

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.