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FDA 510(k)

COMPUTERIZED SPIROMETRY SYSTEM

K-Number: K823922 · 1983-02-24

ApplicantOhio Medical Products
Decision Date1983-02-24
Product CodeBZK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

COMPUTERIZED SPIROMETRY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ohio Medical Products. It received FDA 510(k) clearance on 1983-02-24 under 510(k) number K823922. 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 COMPUTERIZED SPIROMETRY SYSTEM?

COMPUTERIZED SPIROMETRY SYSTEM is a medical device that received FDA 510(k) clearance on 1983-02-24. The listed applicant is Ohio Medical Products. The 510(k) number is K823922.

When did COMPUTERIZED SPIROMETRY SYSTEM receive FDA 510(k) clearance?

COMPUTERIZED SPIROMETRY SYSTEM received FDA 510(k) clearance on 1983-02-24, under 510(k) number K823922.

Who is the listed applicant for COMPUTERIZED SPIROMETRY SYSTEM?

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

What is the FDA product code for COMPUTERIZED SPIROMETRY SYSTEM?

The FDA product code for COMPUTERIZED SPIROMETRY SYSTEM is BZK.

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Other records listing 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.

K841733OHIO WASTE GAS SCAVENGING RESERVOIRK842003OHIO WASTE GAS SCAVENGING INTERFACEK840356OHIO UNITROL II ANESTHESIA GAS MACHINEK841274BAG-TO-VENTILATOR SELECTOR VALVEK840967OHIO HEAT REFLECTING PATCHK840857OHIO 3000 INFANT WARMER SYSTEM

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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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