FDA 510(k)

TIDAL VOLUME MONITOR 150

K-Number: K812046 · 1981-08-07

ApplicantMedix Medical Electronics (U.S.A.), Inc.

Decision Date1981-08-07

Product CodeBZK

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

TIDAL VOLUME MONITOR 150 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 1981-08-07 under 510(k) number K812046. The device is classified under product code BZK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TIDAL VOLUME MONITOR 150?

TIDAL VOLUME MONITOR 150 is a medical device that received FDA 510(k) clearance on 1981-08-07. The listed applicant is Medix Medical Electronics (U.S.A.), Inc.. The 510(k) number is K812046.

When did TIDAL VOLUME MONITOR 150 receive FDA 510(k) clearance?

TIDAL VOLUME MONITOR 150 received FDA 510(k) clearance on 1981-08-07, under 510(k) number K812046.

Who is the listed applicant for TIDAL VOLUME MONITOR 150?

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 TIDAL VOLUME MONITOR 150?

The FDA product code for TIDAL VOLUME MONITOR 150 is BZK.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial 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

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

View all 14 devices →

Related Devices (Code: BZK)

K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.K192584BEACON Caresystem Model 00002144Mermaid Care A/S K192595ExSpiron 2XiRespiratory Motion K180788Gas Module 3Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K173181ExSpiron 1XiRespiratory Motion, Inc.K162131ExSpiron 1XiRespiratory Motion, 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.