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FDA 510(k)

HEAT AND MOISTURE EXCHANGER FILTER (HME)

K-Number: K943915 · 1994-10-14

ApplicantMedicomp, Inc.
Decision Date1994-10-14
Product CodeBYD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HEAT AND MOISTURE EXCHANGER FILTER (HME) is the device name listed in this FDA 510(k) record. The listed applicant is Medicomp, Inc.. It received FDA 510(k) clearance on 1994-10-14 under 510(k) number K943915. 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 AND MOISTURE EXCHANGER FILTER (HME)?

HEAT AND MOISTURE EXCHANGER FILTER (HME) is a medical device that received FDA 510(k) clearance on 1994-10-14. The listed applicant is Medicomp, Inc.. The 510(k) number is K943915.

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

HEAT AND MOISTURE EXCHANGER FILTER (HME) received FDA 510(k) clearance on 1994-10-14, under 510(k) number K943915.

Who is the listed applicant for HEAT AND MOISTURE EXCHANGER FILTER (HME)?

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

What is the FDA product code for HEAT AND MOISTURE EXCHANGER FILTER (HME)?

The FDA product code for HEAT AND MOISTURE EXCHANGER FILTER (HME) is BYD.

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Other records listing Medicomp, 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.

K173170Epicardia AnywhereK161916TelePatch Cardiac MonitorK091696SAVI WIRELESS, MODEL PM500K090834EPICARDIA 5000K043454CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410K981119CARDIOPAL MODEL NUMBER PM20

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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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