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FDA 510(k)

INFAGUARD TM

K-Number: K854705 · 1986-05-01

ApplicantLifewatch Systems, Inc.
Decision Date1986-05-01
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INFAGUARD TM is the device name listed in this FDA 510(k) record. The listed applicant is Lifewatch Systems, Inc.. It received FDA 510(k) clearance on 1986-05-01 under 510(k) number K854705. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFAGUARD TM?

INFAGUARD TM is a medical device that received FDA 510(k) clearance on 1986-05-01. The listed applicant is Lifewatch Systems, Inc.. The 510(k) number is K854705.

When did INFAGUARD TM receive FDA 510(k) clearance?

INFAGUARD TM received FDA 510(k) clearance on 1986-05-01, under 510(k) number K854705.

Who is the listed applicant for INFAGUARD TM?

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

What is the FDA product code for INFAGUARD TM?

The FDA product code for INFAGUARD TM is BZQ.

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 Lifewatch Systems, 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.

K864419LIFEWATCH(R) PORTABLE MONITORING SYSTEMK864487LIFEWATCH SENSOR BELT

Related Devices (Code: BZQ)

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.

K253274BedDot (G1)Intelligent Dots, LLCK251326Respiration Rate algorithmEdwards Lifesciences, LLCK250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLCK243966FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp.

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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