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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 the device name listed in this FDA 510(k) record. The listed applicant is Philips India Limited. It received FDA 510(k) clearance on 2017-11-16 under 510(k) 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. The listed applicant is Philips India Limited. The 510(k) number is K173187.

When did MobileDiagnost M50 receive FDA 510(k) clearance?

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

Who is the listed applicant for MobileDiagnost M50?

The FDA 510(k) record lists Philips India Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MobileDiagnost M50?

The FDA product code for MobileDiagnost M50 is IZL.

Other records listing Philips India Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: IZL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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