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FDA 510(k)

HEAT & MOISTURE EXCHANGER

K-Number: K955008 · 1996-01-30

ApplicantIntertech Resources, Inc.
Decision Date1996-01-30
Product CodeBYD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HEAT & MOISTURE EXCHANGER is the device name listed in this FDA 510(k) record. The listed applicant is Intertech Resources, Inc.. It received FDA 510(k) clearance on 1996-01-30 under 510(k) number K955008. 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 HEAT & MOISTURE EXCHANGER?

HEAT & MOISTURE EXCHANGER is a medical device that received FDA 510(k) clearance on 1996-01-30. The listed applicant is Intertech Resources, Inc.. The 510(k) number is K955008.

When did HEAT & MOISTURE EXCHANGER receive FDA 510(k) clearance?

HEAT & MOISTURE EXCHANGER received FDA 510(k) clearance on 1996-01-30, under 510(k) number K955008.

Who is the listed applicant for HEAT & MOISTURE EXCHANGER?

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

What is the FDA product code for HEAT & MOISTURE EXCHANGER?

The FDA product code for HEAT & MOISTURE EXCHANGER is BYD.

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Other records listing Intertech Resources, 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.

K9613181ST RESPONSE DISPOSABLE MANOMETERK953580HEAT MOISTURE EXCHANGERK952223XENON GAS BREATHING CIRCUITK952062PFT FILTERK952169SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRICK952214SIMS INTERTECH HYPERINFLATION BAG SYSTEM

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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.

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.K953540EEEEdentec Corp.

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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