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FDA 510(k)

HARD SHELL VENTED NASAL MASK

K-Number: K121321 · 2012-11-30

ApplicantSleepnet Corporation
Decision Date2012-11-30
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HARD SHELL VENTED NASAL MASK is the device name listed in this FDA 510(k) record. The listed applicant is Sleepnet Corporation. It received FDA 510(k) clearance on 2012-11-30 under 510(k) number K121321. 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 HARD SHELL VENTED NASAL MASK?

HARD SHELL VENTED NASAL MASK is a medical device that received FDA 510(k) clearance on 2012-11-30. The listed applicant is Sleepnet Corporation. The 510(k) number is K121321.

When did HARD SHELL VENTED NASAL MASK receive FDA 510(k) clearance?

HARD SHELL VENTED NASAL MASK received FDA 510(k) clearance on 2012-11-30, under 510(k) number K121321.

Who is the listed applicant for HARD SHELL VENTED NASAL MASK?

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

What is the FDA product code for HARD SHELL VENTED NASAL MASK?

The FDA product code for HARD SHELL VENTED NASAL MASK is BZD.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sleepnet Corporation 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.

K251847Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskK241830Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented MaskK241943Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented MaskK241661Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented MaskK241520Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented MaskK241469iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask

View all 23 devices →

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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