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FDA 510(k)

PERFORMAX TOTAL FACE MASK

K-Number: K103395 · 2011-03-24

ApplicantRespironics, Inc.
Decision Date2011-03-24
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PERFORMAX 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 2011-03-24 under 510(k) number K103395. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERFORMAX TOTAL FACE MASK?

PERFORMAX TOTAL FACE MASK is a medical device that received FDA 510(k) clearance on 2011-03-24. The listed applicant is Respironics, Inc.. The 510(k) number is K103395.

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

PERFORMAX TOTAL FACE MASK received FDA 510(k) clearance on 2011-03-24, under 510(k) number K103395.

Who is the listed applicant for PERFORMAX 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 TOTAL FACE MASK?

The FDA product code for PERFORMAX TOTAL FACE MASK is BZD.

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Other records listing Respironics, Inc. as applicant

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Related Devices (Code: BZD)

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.

K261262Altis Full Face MaskRespironics, Inc.K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.K253553OrionResmed CorpK254104ResScan EssentialsResmed CorpK251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face MaskDcstar, Inc.K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical 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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