FDA 510(k)

STAR 65

K-Number: K172147 · 2018-05-25

Decision Date2018-05-25

Product CodeMWI

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

STAR 65 is the device name listed in this FDA 510(k) record. The listed applicant is Skanray Technologies Pvt, Ltd.. It received FDA 510(k) clearance on 2018-05-25 under 510(k) number K172147. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAR 65?

STAR 65 is a medical device that received FDA 510(k) clearance on 2018-05-25. The listed applicant is Skanray Technologies Pvt, Ltd.. The 510(k) number is K172147.

When did STAR 65 receive FDA 510(k) clearance?

STAR 65 received FDA 510(k) clearance on 2018-05-25, under 510(k) number K172147.

Who is the listed applicant for STAR 65?

The FDA 510(k) record lists Skanray Technologies Pvt, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STAR 65?

The FDA product code for STAR 65 is MWI.

Related Devices (Code: MWI)

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.

K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc.K253417Masimo Root Monitoring SystemMasimo Corporation K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation K253436c-med0 alphaCosinuss GmbH K250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel Medical K241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV

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.