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FDA 510(k)

MODEL 105 VENTILATOR, MODIFICATION

K-Number: K922477 · 1992-08-24

ApplicantInfrasonics Corp.
Decision Date1992-08-24
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODEL 105 VENTILATOR, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Infrasonics Corp.. It received FDA 510(k) clearance on 1992-08-24 under 510(k) number K922477. 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 MODEL 105 VENTILATOR, MODIFICATION?

MODEL 105 VENTILATOR, MODIFICATION is a medical device that received FDA 510(k) clearance on 1992-08-24. The listed applicant is Infrasonics Corp.. The 510(k) number is K922477.

When did MODEL 105 VENTILATOR, MODIFICATION receive FDA 510(k) clearance?

MODEL 105 VENTILATOR, MODIFICATION received FDA 510(k) clearance on 1992-08-24, under 510(k) number K922477.

Who is the listed applicant for MODEL 105 VENTILATOR, MODIFICATION?

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

What is the FDA product code for MODEL 105 VENTILATOR, MODIFICATION?

The FDA product code for MODEL 105 VENTILATOR, MODIFICATION is CBK.

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Other records listing Infrasonics Corp. 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.

K943106ADULT VENTILATORK952878OXY/STAR LOW FLOW BLENDERK934753STAR BREATHING CIRCUITSK922654VENTILATOR ADULT STAR MODIFICATIONK923704INFANT STAR SERIES 500K920954AIR STAR

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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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