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FDA 510(k)

HEAT MOISTURE EXCHANGER

K-Number: K953580 · 1995-09-15

ApplicantIntertech Resources, Inc.
Decision Date1995-09-15
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 1995-09-15 under 510(k) number K953580. 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 1995-09-15. The listed applicant is Intertech Resources, Inc.. The 510(k) number is K953580.

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

HEAT MOISTURE EXCHANGER received FDA 510(k) clearance on 1995-09-15, under 510(k) number K953580.

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 MANOMETERK955008HEAT & MOISTURE EXCHANGERK952223XENON GAS BREATHING CIRCUITK952169SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRICK952062PFT FILTERK952214SIMS 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.

K955008HEAT & MOISTURE EXCHANGERIntertech Resources, Inc.K954194DISPOSABLE HME/FILTEREngstrom MedicalK953507TYPE 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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