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FDA 510(k)

HEPA FILTERED HEAT AND MOISTURE EXCHANGER

K-Number: K935036 · 1994-01-25

ApplicantIntertech Resources, Inc.
Decision Date1994-01-25
Product CodeBYD
Advisory CommitteeAN
DecisionUnknown

Device Summary

HEPA FILTERED HEAT AND 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 1994-01-25 under 510(k) number K935036. The device is classified under product code BYD. It was reviewed by the AN advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the HEPA FILTERED HEAT AND MOISTURE EXCHANGER?

HEPA FILTERED HEAT AND MOISTURE EXCHANGER is a medical device that received FDA 510(k) clearance on 1994-01-25. The listed applicant is Intertech Resources, Inc.. The 510(k) number is K935036.

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

HEPA FILTERED HEAT AND MOISTURE EXCHANGER received FDA 510(k) clearance on 1994-01-25, under 510(k) number K935036.

Who is the listed applicant for HEPA FILTERED HEAT AND 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 HEPA FILTERED HEAT AND MOISTURE EXCHANGER?

The FDA product code for HEPA FILTERED HEAT AND 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 EXCHANGERK953580HEAT MOISTURE EXCHANGERK952223XENON GAS BREATHING CIRCUITK952169SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRICK952062PFT FILTER

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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 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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