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FDA 510(k)

HEAT/MOISTURE EXCHANGER, HME, W/INTEGRAL FILTER

K-Number: K862020 · 1986-06-30

ApplicantIntertech/Ohio
Decision Date1986-06-30
Product CodeBYD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HEAT/MOISTURE EXCHANGER, HME, W/INTEGRAL FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Intertech/Ohio. It received FDA 510(k) clearance on 1986-06-30 under 510(k) number K862020. 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, HME, W/INTEGRAL FILTER?

HEAT/MOISTURE EXCHANGER, HME, W/INTEGRAL FILTER is a medical device that received FDA 510(k) clearance on 1986-06-30. The listed applicant is Intertech/Ohio. The 510(k) number is K862020.

When did HEAT/MOISTURE EXCHANGER, HME, W/INTEGRAL FILTER receive FDA 510(k) clearance?

HEAT/MOISTURE EXCHANGER, HME, W/INTEGRAL FILTER received FDA 510(k) clearance on 1986-06-30, under 510(k) number K862020.

Who is the listed applicant for HEAT/MOISTURE EXCHANGER, HME, W/INTEGRAL FILTER?

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

What is the FDA product code for HEAT/MOISTURE EXCHANGER, HME, W/INTEGRAL FILTER?

The FDA product code for HEAT/MOISTURE EXCHANGER, HME, W/INTEGRAL FILTER is BYD.

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Other records listing Intertech/Ohio 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.

K895144INTERTECH METERED DOSE ELBOWK890346INTERTECH UNIVERSAL HYDROPHOBIC FILTERK884525PEDIATRIC HUMIDIFIER TUBE W/ TEMPERATURE PORTK884526ADULT RESUSCITATOR WITH MASK AND FILTERK882204RESUSCITATOR VALVE ASSEMBLY W/FILTERK880394FIRST RESPONSE PEDIATRIC EMERGENCY RESUSCITATOR

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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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