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FDA 510(k)

FLO-RITE

K-Number: K041057 · 2004-08-12

ApplicantAmeriflo Corp.
Decision Date2004-08-12
Product CodeNFB
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FLO-RITE is the device name listed in this FDA 510(k) record. The listed applicant is Ameriflo Corp.. It received FDA 510(k) clearance on 2004-08-12 under 510(k) number K041057. The device is classified under product code NFB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLO-RITE?

FLO-RITE is a medical device that received FDA 510(k) clearance on 2004-08-12. The listed applicant is Ameriflo Corp.. The 510(k) number is K041057.

When did FLO-RITE receive FDA 510(k) clearance?

FLO-RITE received FDA 510(k) clearance on 2004-08-12, under 510(k) number K041057.

Who is the listed applicant for FLO-RITE?

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

What is the FDA product code for FLO-RITE?

The FDA product code for FLO-RITE is NFB.

Other records listing Ameriflo Corp. 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.

K060382FLO-RITE, MODEL 478-1; FLO-RITE II, MODEL 478-1; SIMPULSE II, MODEL 478-2S; NUMATIX, MODEL NCD401; SIMPULSE, MODEL 478-1

Related Devices (Code: NFB)

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.

K250322Respond OC Conserving Regulator (130-0800)Responsive RespiratoryK220591ProximaDynasthetics, LLCK221014Effortless Oxygen Conserver System Models Effortless Pro and Effortless MobileEffortless Oxygen, LLCK200401ApogeeIncoba Ltd D/B/A DynarisK151506Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen CannulaSalter LabsK131023THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMENMedical Products, 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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