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FDA 510(k)

IQ NASAL MASK, MODEL P/N 50160

K-Number: K993269 · 1999-10-27

ApplicantSleepnet Corporation
Decision Date1999-10-27
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

IQ NASAL MASK, MODEL P/N 50160 is the device name listed in this FDA 510(k) record. The listed applicant is Sleepnet Corporation. It received FDA 510(k) clearance on 1999-10-27 under 510(k) number K993269. 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 NASAL MASK, MODEL P/N 50160?

IQ NASAL MASK, MODEL P/N 50160 is a medical device that received FDA 510(k) clearance on 1999-10-27. The listed applicant is Sleepnet Corporation. The 510(k) number is K993269.

When did IQ NASAL MASK, MODEL P/N 50160 receive FDA 510(k) clearance?

IQ NASAL MASK, MODEL P/N 50160 received FDA 510(k) clearance on 1999-10-27, under 510(k) number K993269.

Who is the listed applicant for IQ NASAL MASK, MODEL P/N 50160?

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 NASAL MASK, MODEL P/N 50160?

The FDA product code for IQ NASAL MASK, MODEL P/N 50160 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.

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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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