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FDA 510(k)

SPIROX H

K-Number: K812956 · 1982-01-22

ApplicantCairco , Ltd.
Decision Date1982-01-22
Product CodeBZK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPIROX H is the device name listed in this FDA 510(k) record. The listed applicant is Cairco , Ltd.. It received FDA 510(k) clearance on 1982-01-22 under 510(k) number K812956. 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 SPIROX H?

SPIROX H is a medical device that received FDA 510(k) clearance on 1982-01-22. The listed applicant is Cairco , Ltd.. The 510(k) number is K812956.

When did SPIROX H receive FDA 510(k) clearance?

SPIROX H received FDA 510(k) clearance on 1982-01-22, under 510(k) number K812956.

Who is the listed applicant for SPIROX H?

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

What is the FDA product code for SPIROX H?

The FDA product code for SPIROX H is BZK.

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Other records listing Cairco , Ltd. 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.

K812961SHEFFIELD INFANT VENTILATOR MARK 4K812957EAST AUTOCLAVE HUMIDIFIERK812959SPIROX AK812958EAST-FREEMAN VENTILATOR MARK 2K812955EAST WATER UNIT MARK 3K812953RADCLIFFE VENTILATOR MARK 5

View all 9 devices →

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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