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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 the device name listed in this FDA 510(k) record. The listed applicant is Cadwell Industries, Inc.. It received FDA 510(k) clearance on 2024-12-18 under 510(k) 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. The listed applicant is Cadwell Industries, Inc.. The 510(k) number is K242424.

When did Bluebird Single-Use Respiratory Effort Belt receive FDA 510(k) clearance?

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

Who is the listed applicant for Bluebird Single-Use Respiratory Effort Belt?

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

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.

Other records listing Cadwell Industries, Inc. as applicant

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.

View all 12 devices →

Related Devices (Code: MNR)

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.

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.