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FDA 510(k)

HEARTSUITE HEMODYNAMICS 7.10

K-Number: K082421 · 2008-12-17

ApplicantEmageon, Inc.
Decision Date2008-12-17
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEARTSUITE HEMODYNAMICS 7.10 is the device name listed in this FDA 510(k) record. The listed applicant is Emageon, Inc.. It received FDA 510(k) clearance on 2008-12-17 under 510(k) number K082421. 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 HEARTSUITE HEMODYNAMICS 7.10?

HEARTSUITE HEMODYNAMICS 7.10 is a medical device that received FDA 510(k) clearance on 2008-12-17. The listed applicant is Emageon, Inc.. The 510(k) number is K082421.

When did HEARTSUITE HEMODYNAMICS 7.10 receive FDA 510(k) clearance?

HEARTSUITE HEMODYNAMICS 7.10 received FDA 510(k) clearance on 2008-12-17, under 510(k) number K082421.

Who is the listed applicant for HEARTSUITE HEMODYNAMICS 7.10?

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

What is the FDA product code for HEARTSUITE HEMODYNAMICS 7.10?

The FDA product code for HEARTSUITE HEMODYNAMICS 7.10 is DQK.

Related Clinical Trials

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Other records listing Emageon, 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.

K053281EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE)

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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