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)

RESPIR GARD-II FACE MASK CORRUGATED TUBING

K-Number: K853056 · 1985-08-07

ApplicantMarquest Medical Products, Inc.
Decision Date1985-08-07
Product CodeIYT
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RESPIR GARD-II FACE MASK CORRUGATED TUBING is the device name listed in this FDA 510(k) record. The listed applicant is Marquest Medical Products, Inc.. It received FDA 510(k) clearance on 1985-08-07 under 510(k) number K853056. The device is classified under product code IYT. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESPIR GARD-II FACE MASK CORRUGATED TUBING?

RESPIR GARD-II FACE MASK CORRUGATED TUBING is a medical device that received FDA 510(k) clearance on 1985-08-07. The listed applicant is Marquest Medical Products, Inc.. The 510(k) number is K853056.

When did RESPIR GARD-II FACE MASK CORRUGATED TUBING receive FDA 510(k) clearance?

RESPIR GARD-II FACE MASK CORRUGATED TUBING received FDA 510(k) clearance on 1985-08-07, under 510(k) number K853056.

Who is the listed applicant for RESPIR GARD-II FACE MASK CORRUGATED TUBING?

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

What is the FDA product code for RESPIR GARD-II FACE MASK CORRUGATED TUBING?

The FDA product code for RESPIR GARD-II FACE MASK CORRUGATED TUBING is IYT.

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 Marquest Medical Products, 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.

K050066C-CO2 COLORIMETRIC CO2 INDICATORK970478SCT 3000 HEATED HUMIDIFIERK962223WATER CHAMBERS FOR ST 3000 HEATED HUMIDIFIERK962220HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIERK961838RESPIRGARD II, SPIROGARDK960972DISPOSABLE GAS SAMPLING INTERFACE KITS

View all 32 devices →

Related Devices (Code: IYT)

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.

K253942Pulmonex II Xenon System (132-503)Mirion Technologies (Capintec), Inc.K200916Patient Administration SetCyclomedica Australia Pty, Ltd.K953513XENON CIRCUITKing Systems Corp.K952223XENON GAS BREATHING CIRCUITIntertech Resources, Inc.K914747XENON CIRCUITGibeck, Inc.K913416TETLEY PATIENT ADMINISTRATION SETTetley Medical , Ltd.

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.

↑