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FDA 510(k)

Eclipse II with Smart Noise Cancellation

K-Number: K213307 · 2022-01-14

ApplicantCarestream Health, Inc.
Decision Date2022-01-14
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Eclipse II with Smart Noise Cancellation is a medical device manufactured by Carestream Health, Inc.. It received FDA 510(k) clearance on 2022-01-14 under approval number K213307. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Eclipse II with Smart Noise Cancellation?

Eclipse II with Smart Noise Cancellation is a medical device that received FDA 510(k) clearance on 2022-01-14. It is manufactured by Carestream Health, Inc.. The 510(k) number is K213307.

When was Eclipse II with Smart Noise Cancellation approved by the FDA?

Eclipse II with Smart Noise Cancellation received FDA 510(k) clearance on 2022-01-14, under approval number K213307.

What company makes Eclipse II with Smart Noise Cancellation?

Eclipse II with Smart Noise Cancellation is manufactured by Carestream Health, Inc..

What is the FDA product code for Eclipse II with Smart Noise Cancellation?

The FDA product code for Eclipse II with Smart Noise Cancellation is MQB.

Other Devices by Carestream Health, Inc.

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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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