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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 a medical device manufactured by Iorbit Digital Technologies Private Limited. It received FDA 510(k) clearance on 2025-05-16 under approval 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. It is manufactured by Iorbit Digital Technologies Private Limited. The 510(k) number is K243837.

When was iBSM approved by the FDA?

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

What company makes iBSM?

iBSM is manufactured by Iorbit Digital Technologies Private Limited.

What is the FDA product code for iBSM?

The FDA product code for iBSM is DRG.

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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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