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FDA 510(k)

DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME

K-Number: K946209 · 1995-06-08

ApplicantMed-Plastics Intl., Inc.
Decision Date1995-06-08
Product CodeBYD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME is the device name listed in this FDA 510(k) record. The listed applicant is Med-Plastics Intl., Inc.. It received FDA 510(k) clearance on 1995-06-08 under 510(k) number K946209. 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 DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME?

DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME is a medical device that received FDA 510(k) clearance on 1995-06-08. The listed applicant is Med-Plastics Intl., Inc.. The 510(k) number is K946209.

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

DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME received FDA 510(k) clearance on 1995-06-08, under 510(k) number K946209.

Who is the listed applicant for DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME?

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

What is the FDA product code for DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME?

The FDA product code for DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME is BYD.

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Other records listing Med-Plastics Intl., 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.

K942567MASS SPECTROMETRY MONITORING LINES AND CONNECTORSK942568ADULT ANESTHESIA BREATHING CIRCUITK942570MAPLESON D CIRCUITK942569VENTILATOR HOSEK942571HYPER-INFLATION BAGK942572VOLUME VENTILATOR

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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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