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)

SHEFFIELD INFANT VENTILATOR MARK 4

K-Number: K812961 · 1982-03-26

ApplicantCairco , Ltd.
Decision Date1982-03-26
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SHEFFIELD INFANT VENTILATOR MARK 4 is the device name listed in this FDA 510(k) record. The listed applicant is Cairco , Ltd.. It received FDA 510(k) clearance on 1982-03-26 under 510(k) number K812961. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHEFFIELD INFANT VENTILATOR MARK 4?

SHEFFIELD INFANT VENTILATOR MARK 4 is a medical device that received FDA 510(k) clearance on 1982-03-26. The listed applicant is Cairco , Ltd.. The 510(k) number is K812961.

When did SHEFFIELD INFANT VENTILATOR MARK 4 receive FDA 510(k) clearance?

SHEFFIELD INFANT VENTILATOR MARK 4 received FDA 510(k) clearance on 1982-03-26, under 510(k) number K812961.

Who is the listed applicant for SHEFFIELD INFANT VENTILATOR MARK 4?

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 SHEFFIELD INFANT VENTILATOR MARK 4?

The FDA product code for SHEFFIELD INFANT VENTILATOR MARK 4 is CBK.

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 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.

K812957EAST AUTOCLAVE HUMIDIFIERK812956SPIROX HK812959SPIROX AK812958EAST-FREEMAN VENTILATOR MARK 2K812955EAST WATER UNIT MARK 3K812953RADCLIFFE VENTILATOR MARK 5

View all 9 devices →

Related Devices (Code: CBK)

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.

K253647Evita (V800); Evita (V600)Draegerwerk AG & CO KgaaK252663Inbentus VersatileIconic Solutions by Murcia, SLK251888VPAP Pediatric Face MaskHsiner Co., Ltd.K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented FullFisher & Paykel Healthcare, Ltd.K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.

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.

↑