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FDA 510(k)

PERFORMAX PEDIATRIC SE TOTAL FACE MASK

K-Number: K120639 · 2012-07-10

ApplicantRespironics, Inc.
Decision Date2012-07-10
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PERFORMAX PEDIATRIC SE TOTAL FACE MASK is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 2012-07-10 under 510(k) number K120639. 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 PERFORMAX PEDIATRIC SE TOTAL FACE MASK?

PERFORMAX PEDIATRIC SE TOTAL FACE MASK is a medical device that received FDA 510(k) clearance on 2012-07-10. The listed applicant is Respironics, Inc.. The 510(k) number is K120639.

When did PERFORMAX PEDIATRIC SE TOTAL FACE MASK receive FDA 510(k) clearance?

PERFORMAX PEDIATRIC SE TOTAL FACE MASK received FDA 510(k) clearance on 2012-07-10, under 510(k) number K120639.

Who is the listed applicant for PERFORMAX PEDIATRIC SE TOTAL FACE MASK?

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

What is the FDA product code for PERFORMAX PEDIATRIC SE TOTAL FACE MASK?

The FDA product code for PERFORMAX PEDIATRIC SE TOTAL FACE MASK is CBK.

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Other records listing Respironics, Inc. as applicant

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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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