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)

FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS

K-Number: K022260 · 2002-08-29

ApplicantIsolation Systems, Inc.
Decision Date2002-08-29
Product CodeLGM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Isolation Systems, Inc.. It received FDA 510(k) clearance on 2002-08-29 under 510(k) number K022260. The device is classified under product code LGM. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS?

FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS is a medical device that received FDA 510(k) clearance on 2002-08-29. The listed applicant is Isolation Systems, Inc.. The 510(k) number is K022260.

When did FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS receive FDA 510(k) clearance?

FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS received FDA 510(k) clearance on 2002-08-29, under 510(k) number K022260.

Who is the listed applicant for FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS?

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

What is the FDA product code for FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS?

The FDA product code for FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS is LGM.

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

Related Devices (Code: LGM)

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.

K231256Carecube Negative Pressure Isolation ChamberCarecubes, Inc.K163223ORCA (tm) - Operational Rescue Containment ApparatusIsovac Products, LLCK080117PATIENT ISOLATION UNIT, MODEL G019-1000Gentex CorporationK944133MTB 1043 TREATMENT BOOTHMark Solutions, Inc.K912444MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEMRadiometer America, Inc.K896721MODEL 7-AT TREATMENT CHAMBERJ. H. Emerson Co.

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.

↑