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FDA 510(k)

Bluebird Single-Use Respiratory Effort Belt

K-Number: K242424 · 2024-12-18

Decision Date2024-12-18
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Bluebird Single-Use Respiratory Effort Belt is a medical device manufactured by Cadwell Industries, Inc.. It received FDA 510(k) clearance on 2024-12-18 under approval number K242424. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bluebird Single-Use Respiratory Effort Belt?

Bluebird Single-Use Respiratory Effort Belt is a medical device that received FDA 510(k) clearance on 2024-12-18. It is manufactured by Cadwell Industries, Inc.. The 510(k) number is K242424.

When was Bluebird Single-Use Respiratory Effort Belt approved by the FDA?

Bluebird Single-Use Respiratory Effort Belt received FDA 510(k) clearance on 2024-12-18, under approval number K242424.

What company makes Bluebird Single-Use Respiratory Effort Belt?

Bluebird Single-Use Respiratory Effort Belt is manufactured by Cadwell Industries, Inc..

What is the FDA product code for Bluebird Single-Use Respiratory Effort Belt?

The FDA product code for Bluebird Single-Use Respiratory Effort Belt is MNR.

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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.