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FDA 510(k)

OHIO 5400 VOLUME MONITOR

K-Number: K832565 · 1983-09-01

ApplicantAirco/Ohio Medical Products
Decision Date1983-09-01
Product CodeBZK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OHIO 5400 VOLUME MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Airco/Ohio Medical Products. It received FDA 510(k) clearance on 1983-09-01 under 510(k) number K832565. 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 OHIO 5400 VOLUME MONITOR?

OHIO 5400 VOLUME MONITOR is a medical device that received FDA 510(k) clearance on 1983-09-01. The listed applicant is Airco/Ohio Medical Products. The 510(k) number is K832565.

When did OHIO 5400 VOLUME MONITOR receive FDA 510(k) clearance?

OHIO 5400 VOLUME MONITOR received FDA 510(k) clearance on 1983-09-01, under 510(k) number K832565.

Who is the listed applicant for OHIO 5400 VOLUME MONITOR?

The FDA 510(k) record lists Airco/Ohio Medical Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OHIO 5400 VOLUME MONITOR?

The FDA product code for OHIO 5400 VOLUME MONITOR is BZK.

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Other records listing Airco/Ohio Medical Products 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.

K833459COAXIAL VOL. VENTILATOR CIRCUITK833452OHIO GMS ABSORBERK832418OHIO TEMPERATURE SIMULATORK832185OHIO MODEL 922 SPIROMETERK830446OXYGEN MONITOR OHIO 5100K822456OHIO V5A ANESTHESIA VENTILATOR

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Related Devices (Code: BZK)

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.

K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.K192584BEACON Caresystem Model 00002144Mermaid Care A/SK192595ExSpiron 2XiRespiratory MotionK180788Gas 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.

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