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FDA 510(k)

SMARTFLOW

K-Number: K012947 · 2001-10-02

ApplicantFlorence Medical , Ltd.
Decision Date2001-10-02
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SMARTFLOW is the device name listed in this FDA 510(k) record. The listed applicant is Florence Medical , Ltd.. It received FDA 510(k) clearance on 2001-10-02 under 510(k) number K012947. 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 SMARTFLOW?

SMARTFLOW is a medical device that received FDA 510(k) clearance on 2001-10-02. The listed applicant is Florence Medical , Ltd.. The 510(k) number is K012947.

When did SMARTFLOW receive FDA 510(k) clearance?

SMARTFLOW received FDA 510(k) clearance on 2001-10-02, under 510(k) number K012947.

Who is the listed applicant for SMARTFLOW?

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

What is the FDA product code for SMARTFLOW?

The FDA product code for SMARTFLOW 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.

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Other records listing Florence Medical , Ltd. 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.

K020127SMARTFLOW PULSE TRANSMISSION COEFFICIENTK003122SMARTFLOW, MODEL SFIP 2000

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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