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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 the device name listed in this FDA 510(k) record. The listed applicant is Carestream Health, Inc.. It received FDA 510(k) clearance on 2022-01-14 under 510(k) 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. The listed applicant is Carestream Health, Inc.. The 510(k) number is K213307.

When did Eclipse II with Smart Noise Cancellation receive FDA 510(k) clearance?

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

Who is the listed applicant for Eclipse II with Smart Noise Cancellation?

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

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 records listing Carestream Health, Inc. as applicant

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Related Devices (Code: MQB)

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.

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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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