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FDA 510(k)

225 S.I.M.V. VENTILATOR

K-Number: K822635 · 1982-11-16

ApplicantMonaghan Medical Corp.
Decision Date1982-11-16
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

225 S.I.M.V. VENTILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Monaghan Medical Corp.. It received FDA 510(k) clearance on 1982-11-16 under 510(k) number K822635. 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 225 S.I.M.V. VENTILATOR?

225 S.I.M.V. VENTILATOR is a medical device that received FDA 510(k) clearance on 1982-11-16. The listed applicant is Monaghan Medical Corp.. The 510(k) number is K822635.

When did 225 S.I.M.V. VENTILATOR receive FDA 510(k) clearance?

225 S.I.M.V. VENTILATOR received FDA 510(k) clearance on 1982-11-16, under 510(k) number K822635.

Who is the listed applicant for 225 S.I.M.V. VENTILATOR?

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

What is the FDA product code for 225 S.I.M.V. VENTILATOR?

The FDA product code for 225 S.I.M.V. VENTILATOR is CBK.

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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.

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