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FDA 510(k)

MAXI-MISER HUMIDIFIER INSERT 1030

K-Number: K842795 · 1984-10-04

ApplicantNova-Ventrx
Decision Date1984-10-04
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MAXI-MISER HUMIDIFIER INSERT 1030 is the device name listed in this FDA 510(k) record. The listed applicant is Nova-Ventrx. It received FDA 510(k) clearance on 1984-10-04 under 510(k) number K842795. 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 MAXI-MISER HUMIDIFIER INSERT 1030?

MAXI-MISER HUMIDIFIER INSERT 1030 is a medical device that received FDA 510(k) clearance on 1984-10-04. The listed applicant is Nova-Ventrx. The 510(k) number is K842795.

When did MAXI-MISER HUMIDIFIER INSERT 1030 receive FDA 510(k) clearance?

MAXI-MISER HUMIDIFIER INSERT 1030 received FDA 510(k) clearance on 1984-10-04, under 510(k) number K842795.

Who is the listed applicant for MAXI-MISER HUMIDIFIER INSERT 1030?

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

What is the FDA product code for MAXI-MISER HUMIDIFIER INSERT 1030?

The FDA product code for MAXI-MISER HUMIDIFIER INSERT 1030 is BTT.

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Other records listing Nova-Ventrx 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.

K952267CRITERION, CRITERION I.V., MODIFIEDK954480CONDENSATE COLLECTION KITK893760CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004K881207RES-Q 1, 2, 3, 4 AND 5K870382DRV DISP RESUSCIT 3000/BAG ADAPT 3010 & 3011K863756MODIFIED CRITERION VENTILATOR BREATHING CIRCUIT

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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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