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FDA 510(k)

DISPOSABLE HEAT AND MOSITURE EXCHANGER AND HME/FILTER

K-Number: K945657 · 1994-12-07

ApplicantTec II Medical, Inc.
Decision Date1994-12-07
Product CodeBYD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE HEAT AND MOSITURE EXCHANGER AND HME/FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Tec II Medical, Inc.. It received FDA 510(k) clearance on 1994-12-07 under 510(k) number K945657. 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 HEAT AND MOSITURE EXCHANGER AND HME/FILTER?

DISPOSABLE HEAT AND MOSITURE EXCHANGER AND HME/FILTER is a medical device that received FDA 510(k) clearance on 1994-12-07. The listed applicant is Tec II Medical, Inc.. The 510(k) number is K945657.

When did DISPOSABLE HEAT AND MOSITURE EXCHANGER AND HME/FILTER receive FDA 510(k) clearance?

DISPOSABLE HEAT AND MOSITURE EXCHANGER AND HME/FILTER received FDA 510(k) clearance on 1994-12-07, under 510(k) number K945657.

Who is the listed applicant for DISPOSABLE HEAT AND MOSITURE EXCHANGER AND HME/FILTER?

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

What is the FDA product code for DISPOSABLE HEAT AND MOSITURE EXCHANGER AND HME/FILTER?

The FDA product code for DISPOSABLE HEAT AND MOSITURE EXCHANGER AND 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Tec II Medical, 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.

K905148TEMPERATURE PROBE

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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