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FDA 510(k)

FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS

K-Number: K121747 · 2013-03-14

ApplicantIntersurgical Incorporated
Decision Date2013-03-14
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS is the device name listed in this FDA 510(k) record. The listed applicant is Intersurgical Incorporated. It received FDA 510(k) clearance on 2013-03-14 under 510(k) number K121747. 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 FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS?

FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS is a medical device that received FDA 510(k) clearance on 2013-03-14. The listed applicant is Intersurgical Incorporated. The 510(k) number is K121747.

When did FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS receive FDA 510(k) clearance?

FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS received FDA 510(k) clearance on 2013-03-14, under 510(k) number K121747.

Who is the listed applicant for FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS?

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

What is the FDA product code for FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS?

The FDA product code for FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS is BZD.

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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

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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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