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FDA 510(k)

PERFORMAX SE TOTAL FACE MASK

K-Number: K072588 · 2007-12-18

ApplicantRespironics Inc., Sleep & Home Respiratory Group
Decision Date2007-12-18
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PERFORMAX SE TOTAL FACE MASK is the device name listed in this FDA 510(k) record. The listed applicant is Respironics Inc., Sleep & Home Respiratory Group. It received FDA 510(k) clearance on 2007-12-18 under 510(k) number K072588. 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 SE TOTAL FACE MASK?

PERFORMAX SE TOTAL FACE MASK is a medical device that received FDA 510(k) clearance on 2007-12-18. The listed applicant is Respironics Inc., Sleep & Home Respiratory Group. The 510(k) number is K072588.

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

PERFORMAX SE TOTAL FACE MASK received FDA 510(k) clearance on 2007-12-18, under 510(k) number K072588.

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

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

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

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

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Other records listing Respironics Inc., Sleep & Home Respiratory Group 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.

K092835COMFORTGEL NASAL MASKK092648RESPIRONICS PERFORMAX SE TOTAL FACE MASKK090539BIPAP AUTOSV ADVANCEDK091191GAS TRANSFILLK091843COMFORT TWIN NASAL MASKK091066COMFORT TWIN NASAL MASK

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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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