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FDA 510(k)

Perin Health System (PHD80060-2)

K-Number: K252984 · 2026-01-22

ApplicantPerin Health Devices, LLC
Decision Date2026-01-22
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Perin Health System (PHD80060-2) is the device name listed in this FDA 510(k) record. The listed applicant is Perin Health Devices, LLC. It received FDA 510(k) clearance on 2026-01-22 under 510(k) number K252984. 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 Perin Health System (PHD80060-2)?

Perin Health System (PHD80060-2) is a medical device that received FDA 510(k) clearance on 2026-01-22. The listed applicant is Perin Health Devices, LLC. The 510(k) number is K252984.

When did Perin Health System (PHD80060-2) receive FDA 510(k) clearance?

Perin Health System (PHD80060-2) received FDA 510(k) clearance on 2026-01-22, under 510(k) number K252984.

Who is the listed applicant for Perin Health System (PHD80060-2)?

The FDA 510(k) record lists Perin Health Devices, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Perin Health System (PHD80060-2)?

The FDA product code for Perin Health System (PHD80060-2) is DRG.

Related Clinical Trials

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.

NCT07774169Noninvasive Blood Pressure Validation StudyCOMPLETED

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.K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.K250259TeleRehab Aermos Cardiopulmonary RehabilitationThe ScottCare CorporationK243837iBSMIorbit Digital Technologies Private LimitedK242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.K241101BioButton SystemBiointellisense, 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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