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FDA 510(k)

SM-IV

K-Number: K232185 · 2023-08-21

ApplicantSedecal., Sa.
Decision Date2023-08-21
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SM-IV is a medical device manufactured by Sedecal., Sa.. It received FDA 510(k) clearance on 2023-08-21 under approval number K232185. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SM-IV?

SM-IV is a medical device that received FDA 510(k) clearance on 2023-08-21. It is manufactured by Sedecal., Sa.. The 510(k) number is K232185.

When was SM-IV approved by the FDA?

SM-IV received FDA 510(k) clearance on 2023-08-21, under approval number K232185.

What company makes SM-IV?

SM-IV is manufactured by Sedecal., Sa..

What is the FDA product code for SM-IV?

The FDA product code for SM-IV is IZL.

Other Devices by Sedecal., Sa.

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Related Devices (Code: IZL)

K163063UC-5000 Mobile X-RaySource-Ray, Inc. K162990Optima XR240amxGe Medical Systems, LLC K162278Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. K162687Paragon 2Meridian Medical Systems, LLC K161345RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIRSedecal., Sa. K153059HF1202H PowerPlus Portable X-ray EquipmentMinxray, Inc.

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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