Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AccuCheck

K-Number: K223834 · 2023-07-20

ApplicantManteia Technologies Co., Ltd.
Decision Date2023-07-20
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AccuCheck is a medical device manufactured by Manteia Technologies Co., Ltd.. It received FDA 510(k) clearance on 2023-07-20 under approval number K223834. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AccuCheck?

AccuCheck is a medical device that received FDA 510(k) clearance on 2023-07-20. It is manufactured by Manteia Technologies Co., Ltd.. The 510(k) number is K223834.

When was AccuCheck approved by the FDA?

AccuCheck received FDA 510(k) clearance on 2023-07-20, under approval number K223834.

What company makes AccuCheck?

AccuCheck is manufactured by Manteia Technologies Co., Ltd..

What is the FDA product code for AccuCheck?

The FDA product code for AccuCheck is IYE.

Other Devices by Manteia Technologies Co., Ltd.

K223724MOZI TPS K221706AccuContour K250780ARTAssistant K250696AccuCheck K251351AccuContour 4.0

Related Devices (Code: IYE)

K162476Varian High Energy Linear AcceleratorVarian Medical Systems, Inc. K161400ImagingRing SystemMedphoton GmbH K162468ClearCheckRadformation K162355Raycast MammoRx Carbon Fibre Breast BoardOrfit Industries NV K162577Dosimetry Check Version 5 Release 1Math Resolutions, LLC K162265CushionCast Moldable CushionsIzi Medical Products, LLC

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.

↑