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FDA 510(k)

PRISMAFLO

K-Number: K020103 · 2002-07-24

ApplicantStihler Electronic GmbH
Decision Date2002-07-24
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PRISMAFLO is the device name listed in this FDA 510(k) record. The listed applicant is Stihler Electronic GmbH. It received FDA 510(k) clearance on 2002-07-24 under 510(k) number K020103. The device is classified under product code KOC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRISMAFLO?

PRISMAFLO is a medical device that received FDA 510(k) clearance on 2002-07-24. The listed applicant is Stihler Electronic GmbH. The 510(k) number is K020103.

When did PRISMAFLO receive FDA 510(k) clearance?

PRISMAFLO received FDA 510(k) clearance on 2002-07-24, under 510(k) number K020103.

Who is the listed applicant for PRISMAFLO?

The FDA 510(k) record lists Stihler Electronic GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRISMAFLO?

The FDA product code for PRISMAFLO is KOC.

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Other records listing Stihler Electronic GmbH 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.

K260278ThermAffyx(TM) Patient Safety SystemK202197Astopad Patient Warming SystemK082758PRISMAFLO IIK082765ASTOFLO PLUSK991159PRISMATHERM II, ASTOLINEK991160ASTOTHERM PLUS, ASTOTUBES, ASTOLINE

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Related Devices (Code: KOC)

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.

K242479BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PUNIKKISO CO., LTD.K242176BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)NIKKISO CO., LTD.K231589Blood Tubing Lines for Hemodialysis AV06C-ENIKKISO CO., LTD.K230514Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 SeriesNIKKISO CO., LTD.K201207CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin LineFresenius Medical Care Renal Therapies Group, LLCK172238CAREline Airless Hemodialysis Blood Tubing SetsFresenius Medical Care Renal Therapies Group, 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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