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FDA 510(k)

DUALTHERM(R) CARDIAC OUTPUT COMPUTER

K-Number: K925285 · 1993-07-21

ApplicantB. Braun of America, Inc.
Decision Date1993-07-21
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DUALTHERM(R) CARDIAC OUTPUT COMPUTER is the device name listed in this FDA 510(k) record. The listed applicant is B. Braun of America, Inc.. It received FDA 510(k) clearance on 1993-07-21 under 510(k) number K925285. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUALTHERM(R) CARDIAC OUTPUT COMPUTER?

DUALTHERM(R) CARDIAC OUTPUT COMPUTER is a medical device that received FDA 510(k) clearance on 1993-07-21. The listed applicant is B. Braun of America, Inc.. The 510(k) number is K925285.

When did DUALTHERM(R) CARDIAC OUTPUT COMPUTER receive FDA 510(k) clearance?

DUALTHERM(R) CARDIAC OUTPUT COMPUTER received FDA 510(k) clearance on 1993-07-21, under 510(k) number K925285.

Who is the listed applicant for DUALTHERM(R) CARDIAC OUTPUT COMPUTER?

The FDA 510(k) record lists B. Braun of America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DUALTHERM(R) CARDIAC OUTPUT COMPUTER?

The FDA product code for DUALTHERM(R) CARDIAC OUTPUT COMPUTER is DQK.

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Other records listing B. Braun of America, Inc. as applicant

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Related Devices (Code: DQK)

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.

K261729EnSite™ X EP SystemAbbott MedicalK262005Affera Integrated Mapping SystemMedtronic, Inc.K253692AVVIGO™+ Multi-Modality Guidance SystemBoston ScientificK253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC

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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