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FDA 510(k)

iQ 2 Nasal Mask, Phantom 2 Nasal Mask

K-Number: K211274 · 2022-01-10

ApplicantSleepnet Corporation
Decision Date2022-01-10
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

iQ 2 Nasal Mask, Phantom 2 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 2022-01-10 under 510(k) number K211274. 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 iQ 2 Nasal Mask, Phantom 2 Nasal Mask?

iQ 2 Nasal Mask, Phantom 2 Nasal Mask is a medical device that received FDA 510(k) clearance on 2022-01-10. The listed applicant is Sleepnet Corporation. The 510(k) number is K211274.

When did iQ 2 Nasal Mask, Phantom 2 Nasal Mask receive FDA 510(k) clearance?

iQ 2 Nasal Mask, Phantom 2 Nasal Mask received FDA 510(k) clearance on 2022-01-10, under 510(k) number K211274.

Who is the listed applicant for iQ 2 Nasal Mask, Phantom 2 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 iQ 2 Nasal Mask, Phantom 2 Nasal Mask?

The FDA product code for iQ 2 Nasal Mask, Phantom 2 Nasal Mask is BZD.

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 10 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.

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.K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc)

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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