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FDA 510(k)

BUBBLE HUMIDIFIERS

K-Number: K823143 · 1982-11-29

ApplicantSeven Harvest Intl. Import & Export
Decision Date1982-11-29
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BUBBLE HUMIDIFIERS is the device name listed in this FDA 510(k) record. The listed applicant is Seven Harvest Intl. Import & Export. It received FDA 510(k) clearance on 1982-11-29 under 510(k) number K823143. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BUBBLE HUMIDIFIERS?

BUBBLE HUMIDIFIERS is a medical device that received FDA 510(k) clearance on 1982-11-29. The listed applicant is Seven Harvest Intl. Import & Export. The 510(k) number is K823143.

When did BUBBLE HUMIDIFIERS receive FDA 510(k) clearance?

BUBBLE HUMIDIFIERS received FDA 510(k) clearance on 1982-11-29, under 510(k) number K823143.

Who is the listed applicant for BUBBLE HUMIDIFIERS?

The FDA 510(k) record lists Seven Harvest Intl. Import & Export as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BUBBLE HUMIDIFIERS?

The FDA product code for BUBBLE HUMIDIFIERS is BTT.

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Other records listing Seven Harvest Intl. Import & Export 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.

K940793DOUBLE TRACH SWIVEL CONNECTORK823506NASAL CANNULAK823141OXYGEN MASKSK823142OXYGEN TUBINGSK820709AIRWAYSK813074CONNECTORS & ADAPTERS

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Related Devices (Code: BTT)

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.

K262268Optiflow Oxygen Kit (AA484J)Fisher and Paykel Healthcare LimitedK254078HVT 2.0Vapotherm, Inc.K251448FL-10000U Respiratory HumidifierFlexicare Medical Limited.K251419Laboratorios Biogalenic Sterile Water for Inhalation, USPLaboratorios Biogalenic S.A. DE C.V.K253479Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)Fisher & Paykel Healthcare, Ltd.K250312Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra SmallMedline Industries, LP

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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