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)

MobileDiagnost M50

K-Number: K173187 · 2017-11-16

ApplicantPhilips India Limited
Decision Date2017-11-16
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MobileDiagnost M50 is a medical device manufactured by Philips India Limited. It received FDA 510(k) clearance on 2017-11-16 under approval number K173187. 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 MobileDiagnost M50?

MobileDiagnost M50 is a medical device that received FDA 510(k) clearance on 2017-11-16. It is manufactured by Philips India Limited. The 510(k) number is K173187.

When was MobileDiagnost M50 approved by the FDA?

MobileDiagnost M50 received FDA 510(k) clearance on 2017-11-16, under approval number K173187.

What company makes MobileDiagnost M50?

MobileDiagnost M50 is manufactured by Philips India Limited.

What is the FDA product code for MobileDiagnost M50?

The FDA product code for MobileDiagnost M50 is IZL.

Other Devices by Philips India Limited

K203623StentBoost Mobile

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.

↑