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FDA 510(k)

IBM iConnect Access

K-Number: K203104 · 2021-01-26

Decision Date2021-01-26
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IBM iConnect Access is a medical device manufactured by Merge Healthcare Incorporated. It received FDA 510(k) clearance on 2021-01-26 under approval number K203104. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IBM iConnect Access?

IBM iConnect Access is a medical device that received FDA 510(k) clearance on 2021-01-26. It is manufactured by Merge Healthcare Incorporated. The 510(k) number is K203104.

When was IBM iConnect Access approved by the FDA?

IBM iConnect Access received FDA 510(k) clearance on 2021-01-26, under approval number K203104.

What company makes IBM iConnect Access?

IBM iConnect Access is manufactured by Merge Healthcare Incorporated.

What is the FDA product code for IBM iConnect Access?

The FDA product code for IBM iConnect Access is LLZ.

Other Devices by Merge Healthcare Incorporated

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Related Devices (Code: LLZ)

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.