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FDA 510(k)

Ultrasound System 1300

K-Number: K231764 · 2023-10-23

ApplicantBk Medical Aps
Decision Date2023-10-23
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Ultrasound System 1300 is a medical device manufactured by Bk Medical Aps. It received FDA 510(k) clearance on 2023-10-23 under approval number K231764. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ultrasound System 1300?

Ultrasound System 1300 is a medical device that received FDA 510(k) clearance on 2023-10-23. It is manufactured by Bk Medical Aps. The 510(k) number is K231764.

When was Ultrasound System 1300 approved by the FDA?

Ultrasound System 1300 received FDA 510(k) clearance on 2023-10-23, under approval number K231764.

What company makes Ultrasound System 1300?

Ultrasound System 1300 is manufactured by Bk Medical Aps.

What is the FDA product code for Ultrasound System 1300?

The FDA product code for Ultrasound System 1300 is IYN.

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Other Devices by Bk Medical Aps

K161960bk2300 K180737Ultrasound Scanner System bk2300 K173569Ultrasound System 1300 K222441Ultrasound System 2300 K223830Ultrasound System 2300

Related Devices (Code: IYN)

K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi , Ltd. K163138Clarius Ultrasound SystemClarius Mobile Health Corp. K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics K162583ALOKA LISENDO 880Hitachi , Ltd. K163020Xperius Ultrasound SystemPhilips Health Care

Official Source

View on FDA Database →

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

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