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)

INFANT APNEA MONITOR MODEL 100

K-Number: K812045 · 1981-09-24

ApplicantMedix Medical Electronics (U.S.A.), Inc.
Decision Date1981-09-24
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INFANT APNEA MONITOR MODEL 100 is the device name listed in this FDA 510(k) record. The listed applicant is Medix Medical Electronics (U.S.A.), Inc.. It received FDA 510(k) clearance on 1981-09-24 under 510(k) number K812045. 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 INFANT APNEA MONITOR MODEL 100?

INFANT APNEA MONITOR MODEL 100 is a medical device that received FDA 510(k) clearance on 1981-09-24. The listed applicant is Medix Medical Electronics (U.S.A.), Inc.. The 510(k) number is K812045.

When did INFANT APNEA MONITOR MODEL 100 receive FDA 510(k) clearance?

INFANT APNEA MONITOR MODEL 100 received FDA 510(k) clearance on 1981-09-24, under 510(k) number K812045.

Who is the listed applicant for INFANT APNEA MONITOR MODEL 100?

The FDA 510(k) record lists Medix Medical Electronics (U.S.A.), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INFANT APNEA MONITOR MODEL 100?

The FDA product code for INFANT APNEA MONITOR MODEL 100 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 Medix Medical Electronics (U.S.A.), 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.

K861040ENTERNAL INFUSER MULTIPUMP 203K861001PARENTERAL INFUSER MEDIPUMP 204K853393INSULIN PUMP INSUMAT 229K852433INFUSAFE 205 CATOLOG NO. 205.000K813562SYRINGE DRIVER 209K812039SPIROMETER 210/211

View all 14 devices →

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.

↑