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FDA 510(k)

731 Series Ventilator

K-Number: K233486 · 2024-12-13

ApplicantZOLL Medical Corporation
Decision Date2024-12-13
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

731 Series Ventilator is the device name listed in this FDA 510(k) record. The listed applicant is ZOLL Medical Corporation. It received FDA 510(k) clearance on 2024-12-13 under 510(k) number K233486. 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 731 Series Ventilator?

731 Series Ventilator is a medical device that received FDA 510(k) clearance on 2024-12-13. The listed applicant is ZOLL Medical Corporation. The 510(k) number is K233486.

When did 731 Series Ventilator receive FDA 510(k) clearance?

731 Series Ventilator received FDA 510(k) clearance on 2024-12-13, under 510(k) number K233486.

Who is the listed applicant for 731 Series Ventilator?

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

What is the FDA product code for 731 Series Ventilator?

The FDA product code for 731 Series Ventilator is CBK.

Related Clinical Trials

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NCT07622472Remote Monitoring and Optimization of Heart Failure TherapyNOT_YET_RECRUITING

Other records listing ZOLL Medical Corporation 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.

PMA P160015Automated external defibrillators (non-wearable)PMA P160022Automated external defibrillators (non-wearable)PMA P160033Automated external defibrillators (non-wearable)PMA P890057VENTILATOR, HIGH FREQUENCYPMA P110024Combination compression/decompression manual chest pump with impedance respiratory valveK202375ZOLL Propaq M

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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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