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FDA 510(k)

PROSOLV CARDIVASCULAR VIEWER; ANALYZER; SERVER; VERSION 2.5.9

K-Number: K023112 · 2002-12-17

ApplicantProblem Solving Concepts, Inc.
Decision Date2002-12-17
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PROSOLV CARDIVASCULAR VIEWER; ANALYZER; SERVER; VERSION 2.5.9 is the device name listed in this FDA 510(k) record. The listed applicant is Problem Solving Concepts, Inc.. It received FDA 510(k) clearance on 2002-12-17 under 510(k) number K023112. 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 PROSOLV CARDIVASCULAR VIEWER; ANALYZER; SERVER; VERSION 2.5.9?

PROSOLV CARDIVASCULAR VIEWER; ANALYZER; SERVER; VERSION 2.5.9 is a medical device that received FDA 510(k) clearance on 2002-12-17. The listed applicant is Problem Solving Concepts, Inc.. The 510(k) number is K023112.

When did PROSOLV CARDIVASCULAR VIEWER; ANALYZER; SERVER; VERSION 2.5.9 receive FDA 510(k) clearance?

PROSOLV CARDIVASCULAR VIEWER; ANALYZER; SERVER; VERSION 2.5.9 received FDA 510(k) clearance on 2002-12-17, under 510(k) number K023112.

Who is the listed applicant for PROSOLV CARDIVASCULAR VIEWER; ANALYZER; SERVER; VERSION 2.5.9?

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

What is the FDA product code for PROSOLV CARDIVASCULAR VIEWER; ANALYZER; SERVER; VERSION 2.5.9?

The FDA product code for PROSOLV CARDIVASCULAR VIEWER; ANALYZER; SERVER; VERSION 2.5.9 is DQK.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Problem Solving Concepts, 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.

K993750PROSOLV ECHOVIEWER, PROSOLV ECHOVIEWER SE, PROSOLV ECHOANALYZER, PROSOLV ECHOSERV, PROSOLV ECHO

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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