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FDA 510(k)

SMARTFLOW, MODEL SFIP 2000

K-Number: K003122 · 2001-05-14

ApplicantFlorence Medical , Ltd.
Decision Date2001-05-14
Product CodeDSK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SMARTFLOW, MODEL SFIP 2000 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 2001-05-14 under 510(k) number K003122. The device is classified under product code DSK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMARTFLOW, MODEL SFIP 2000?

SMARTFLOW, MODEL SFIP 2000 is a medical device that received FDA 510(k) clearance on 2001-05-14. The listed applicant is Florence Medical , Ltd.. The 510(k) number is K003122.

When did SMARTFLOW, MODEL SFIP 2000 receive FDA 510(k) clearance?

SMARTFLOW, MODEL SFIP 2000 received FDA 510(k) clearance on 2001-05-14, under 510(k) number K003122.

Who is the listed applicant for SMARTFLOW, MODEL SFIP 2000?

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, MODEL SFIP 2000?

The FDA product code for SMARTFLOW, MODEL SFIP 2000 is DSK.

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 COEFFICIENTK012947SMARTFLOW

Related Devices (Code: DSK)

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.

K231586Endophys Blood Pressure Monitor model BPM-30Endophys Technologies, LLCK160945Endophys Blood Pressure MonitorEndophys Holdings, LLCK080670MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEMAtcor MedicalK070795SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEMAtcor Medical Pty, Ltd.K033738MONITORING SYSTEM, MODEL ARGUS PB-2200Schiller AGK021517ABP FOR WINDOWSRozinn Electronics, Inc.

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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