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FDA 510(k)

DISPOSABLE HME/FILTER

K-Number: K954194 · 1995-10-20

ApplicantEngstrom Medical
Decision Date1995-10-20
Product CodeBYD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE HME/FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Engstrom Medical. It received FDA 510(k) clearance on 1995-10-20 under 510(k) number K954194. 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 DISPOSABLE HME/FILTER?

DISPOSABLE HME/FILTER is a medical device that received FDA 510(k) clearance on 1995-10-20. The listed applicant is Engstrom Medical. The 510(k) number is K954194.

When did DISPOSABLE HME/FILTER receive FDA 510(k) clearance?

DISPOSABLE HME/FILTER received FDA 510(k) clearance on 1995-10-20, under 510(k) number K954194.

Who is the listed applicant for DISPOSABLE HME/FILTER?

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

What is the FDA product code for DISPOSABLE HME/FILTER?

The FDA product code for DISPOSABLE HME/FILTER is BYD.

Related Clinical Trials

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.

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Other records listing Engstrom Medical 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.

K954197DISPOSABLE FLEX TUBE

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.K953580HEAT 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.K953540EEEEdentec Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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