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FDA 510(k)

WARM N WET HME W/LUER ADAPTER

K-Number: K953619 · 1995-08-25

ApplicantHospitak, Inc.
Decision Date1995-08-25
Product CodeBYD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

WARM N WET HME W/LUER ADAPTER is the device name listed in this FDA 510(k) record. The listed applicant is Hospitak, Inc.. It received FDA 510(k) clearance on 1995-08-25 under 510(k) number K953619. The device is classified under product code BYD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WARM N WET HME W/LUER ADAPTER?

WARM N WET HME W/LUER ADAPTER is a medical device that received FDA 510(k) clearance on 1995-08-25. The listed applicant is Hospitak, Inc.. The 510(k) number is K953619.

When did WARM N WET HME W/LUER ADAPTER receive FDA 510(k) clearance?

WARM N WET HME W/LUER ADAPTER received FDA 510(k) clearance on 1995-08-25, under 510(k) number K953619.

Who is the listed applicant for WARM N WET HME W/LUER ADAPTER?

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

What is the FDA product code for WARM N WET HME W/LUER ADAPTER?

The FDA product code for WARM N WET HME W/LUER ADAPTER is BYD.

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Other records listing Hospitak, 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.

K955483TRACH MASK MODEL (245, 246)K954787ILLUMINATORK953620WARM N WET HMEF W/LUER ADAPTERK915750DISPOSABLE BACTERIAL BREATHNG FILTERK920842AEROSOL DELIVERY SYSTEMSK915228DISPOSABLE CO2 GAS SAMPLING/OXYGEN DELIVERY CANNUL

View all 27 devices →

Related Devices (Code: BYD)

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.

K955008HEAT & MOISTURE EXCHANGERIntertech Resources, Inc.K954194DISPOSABLE HME/FILTEREngstrom MedicalK953580HEAT MOISTURE EXCHANGERIntertech Resources, Inc.K953507TYPE 1 & 2 (HUMIDAIR I & II)Icor ABK953544HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHTGibeck, Inc.K953620WARM N WET HMEF W/LUER ADAPTERHospitak, Inc.

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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