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FDA 510(k)

THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK

K-Number: K081670 · 2008-10-09

ApplicantCardinal Health 207, Inc.
Decision Date2008-10-09
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health 207, Inc.. It received FDA 510(k) clearance on 2008-10-09 under 510(k) number K081670. 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 THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK?

THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK is a medical device that received FDA 510(k) clearance on 2008-10-09. The listed applicant is Cardinal Health 207, Inc.. The 510(k) number is K081670.

When did THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK receive FDA 510(k) clearance?

THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK received FDA 510(k) clearance on 2008-10-09, under 510(k) number K081670.

Who is the listed applicant for THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK?

The FDA 510(k) record lists Cardinal Health 207, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK?

The FDA product code for THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK is CBK.

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Other records listing Cardinal Health 207, Inc. 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.

K093094VELA VENTILATORK092484HELIOX LOW FLOW SENTRY BLENDERK093124PURESOM NASAL MASK-SMALL, PURESOM NASAL MASK-MEDIUM, PURESOM NASAL MASK-LARGE, MODELS 11924-01, 11924-02, 11924-03K081837AVEA VENTILATOR

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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