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FDA 510(k)

VAPOR-PHASE HUMIDIFIER SYSTEM

K-Number: K831556 · 1983-07-19

ApplicantCygnus Research Corp.
Decision Date1983-07-19
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VAPOR-PHASE HUMIDIFIER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cygnus Research Corp.. It received FDA 510(k) clearance on 1983-07-19 under 510(k) number K831556. 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 VAPOR-PHASE HUMIDIFIER SYSTEM?

VAPOR-PHASE HUMIDIFIER SYSTEM is a medical device that received FDA 510(k) clearance on 1983-07-19. The listed applicant is Cygnus Research Corp.. The 510(k) number is K831556.

When did VAPOR-PHASE HUMIDIFIER SYSTEM receive FDA 510(k) clearance?

VAPOR-PHASE HUMIDIFIER SYSTEM received FDA 510(k) clearance on 1983-07-19, under 510(k) number K831556.

Who is the listed applicant for VAPOR-PHASE HUMIDIFIER SYSTEM?

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

What is the FDA product code for VAPOR-PHASE HUMIDIFIER SYSTEM?

The FDA product code for VAPOR-PHASE HUMIDIFIER SYSTEM is BTT.

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Other records listing Cygnus Research 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.

K831163LO-COMP RESERVOIR-RE-1000K830923TEMP-CHECK ADAPTOR, STRAIGHT CONFIGURAK830922TEMP-CHECK ADAPTOR, TEE-CONFIGURATIONK830921TEMP-CHECK ADAPTOR, Y-CONFIGURATION

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

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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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