Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DISPOSABLE HEAT & MOSITURE EXCHANGER & FILTER/HME

K-Number: K944194 · 1994-09-13

ApplicantMed-Tek Innovations, Inc.
Decision Date1994-09-13
Product CodeBYD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE HEAT & MOSITURE EXCHANGER & FILTER/HME is the device name listed in this FDA 510(k) record. The listed applicant is Med-Tek Innovations, Inc.. It received FDA 510(k) clearance on 1994-09-13 under 510(k) number K944194. 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 & MOSITURE EXCHANGER & FILTER/HME?

DISPOSABLE HEAT & MOSITURE EXCHANGER & FILTER/HME is a medical device that received FDA 510(k) clearance on 1994-09-13. The listed applicant is Med-Tek Innovations, Inc.. The 510(k) number is K944194.

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

DISPOSABLE HEAT & MOSITURE EXCHANGER & FILTER/HME received FDA 510(k) clearance on 1994-09-13, under 510(k) number K944194.

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

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

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

The FDA product code for DISPOSABLE HEAT & MOSITURE EXCHANGER & FILTER/HME 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 Med-Tek Innovations, 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.

K913474RESPIRE DISPOSABLE PULMONARY RESUSCITATORK905288ANESTHESIA/RESPIRATORY FACE MASK, VARIOUS SIZES

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.

↑