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FDA 510(k)

SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTED

K-Number: K063806 · 2007-05-17

ApplicantSleepnet Corporation
Decision Date2007-05-17
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTED is the device name listed in this FDA 510(k) record. The listed applicant is Sleepnet Corporation. It received FDA 510(k) clearance on 2007-05-17 under 510(k) number K063806. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTED?

SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTED is a medical device that received FDA 510(k) clearance on 2007-05-17. The listed applicant is Sleepnet Corporation. The 510(k) number is K063806.

When did SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTED receive FDA 510(k) clearance?

SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTED received FDA 510(k) clearance on 2007-05-17, under 510(k) number K063806.

Who is the listed applicant for SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTED?

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 SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTED?

The FDA product code for SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTED is CBK.

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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: CBK)

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.

K253647Evita (V800); Evita (V600)Draegerwerk AG & CO KgaaK252663Inbentus VersatileIconic Solutions by Murcia, SLK251888VPAP Pediatric Face MaskHsiner Co., Ltd.K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented FullFisher & Paykel Healthcare, Ltd.K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics 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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