FDA 510(k)

Patient Status Engine

K-Number: K172329 · 2018-04-23

Decision Date2018-04-23

Product CodeDRG

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Patient Status Engine is the device name listed in this FDA 510(k) record. The listed applicant is Isansys Lifecare, Ltd.. It received FDA 510(k) clearance on 2018-04-23 under 510(k) number K172329. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Patient Status Engine?

Patient Status Engine is a medical device that received FDA 510(k) clearance on 2018-04-23. The listed applicant is Isansys Lifecare, Ltd.. The 510(k) number is K172329.

When did Patient Status Engine receive FDA 510(k) clearance?

Patient Status Engine received FDA 510(k) clearance on 2018-04-23, under 510(k) number K172329.

Who is the listed applicant for Patient Status Engine?

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

What is the FDA product code for Patient Status Engine?

The FDA product code for Patient Status Engine is DRG.

Related Devices (Code: DRG)

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.

K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.K250259TeleRehab Aermos Cardiopulmonary RehabilitationThe ScottCare Corporation K243837iBSMIorbit Digital Technologies Private Limited K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.

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.