FDA 510(k)

iBSM

K-Number: K243837 · 2025-05-16

ApplicantIorbit Digital Technologies Private Limited

Decision Date2025-05-16

Product CodeDRG

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

iBSM is the device name listed in this FDA 510(k) record. The listed applicant is Iorbit Digital Technologies Private Limited. It received FDA 510(k) clearance on 2025-05-16 under 510(k) number K243837. 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 iBSM?

iBSM is a medical device that received FDA 510(k) clearance on 2025-05-16. The listed applicant is Iorbit Digital Technologies Private Limited. The 510(k) number is K243837.

When did iBSM receive FDA 510(k) clearance?

iBSM received FDA 510(k) clearance on 2025-05-16, under 510(k) number K243837.

Who is the listed applicant for iBSM?

The FDA 510(k) record lists Iorbit Digital Technologies Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iBSM?

The FDA product code for iBSM 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 K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.K241101BioButton SystemBiointellisense, 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.