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FDA 510(k)

PREFILLED HUMIDIFIER

K-Number: K760566 · 1976-10-15

ApplicantForegger Air Products & Chem., Inc.
Decision Date1976-10-15
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PREFILLED HUMIDIFIER is the device name listed in this FDA 510(k) record. The listed applicant is Foregger Air Products & Chem., Inc.. It received FDA 510(k) clearance on 1976-10-15 under 510(k) number K760566. 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 PREFILLED HUMIDIFIER?

PREFILLED HUMIDIFIER is a medical device that received FDA 510(k) clearance on 1976-10-15. The listed applicant is Foregger Air Products & Chem., Inc.. The 510(k) number is K760566.

When did PREFILLED HUMIDIFIER receive FDA 510(k) clearance?

PREFILLED HUMIDIFIER received FDA 510(k) clearance on 1976-10-15, under 510(k) number K760566.

Who is the listed applicant for PREFILLED HUMIDIFIER?

The FDA 510(k) record lists Foregger Air Products & Chem., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PREFILLED HUMIDIFIER?

The FDA product code for PREFILLED HUMIDIFIER is BTT.

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 Foregger Air Products & Chem., Inc. 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.

K760565VENTILATOR CIRCUITSK760567BACTERIA FILTER

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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