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FDA 510(k)

cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems

K-Number: K243455 · 2025-07-31

ApplicantRoche Molecular Systems, Inc.
Decision Date2025-07-31
Product CodeQOF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems is a medical device manufactured by Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2025-07-31 under approval number K243455. The device is classified under product code QOF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems?

cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems is a medical device that received FDA 510(k) clearance on 2025-07-31. It is manufactured by Roche Molecular Systems, Inc.. The 510(k) number is K243455.

When was cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems approved by the FDA?

cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems received FDA 510(k) clearance on 2025-07-31, under approval number K243455.

What company makes cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems?

cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems is manufactured by Roche Molecular Systems, Inc..

What is the FDA product code for cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems?

The FDA product code for cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems is QOF.

Related Clinical Trials

NCT07552025 Detection of Respiratory Events Using Acoustic Monitoring in Extremely Preterm Infants NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41568227 A frugal arduino-based spirometer for low-resource settings: design, development and validation of a preliminary prototype. Frontiers in bioengineering and biotechnology (2025)

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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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