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FDA 510(k)

Innova Nasal Non-Vented Mask

K-Number: K203601 · 2021-04-30

ApplicantSleepnet Corporation
Decision Date2021-04-30
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Innova Nasal Non-Vented Mask is a medical device manufactured by Sleepnet Corporation. It received FDA 510(k) clearance on 2021-04-30 under approval number K203601. 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 Innova Nasal Non-Vented Mask?

Innova Nasal Non-Vented Mask is a medical device that received FDA 510(k) clearance on 2021-04-30. It is manufactured by Sleepnet Corporation. The 510(k) number is K203601.

When was Innova Nasal Non-Vented Mask approved by the FDA?

Innova Nasal Non-Vented Mask received FDA 510(k) clearance on 2021-04-30, under approval number K203601.

What company makes Innova Nasal Non-Vented Mask?

Innova Nasal Non-Vented Mask is manufactured by Sleepnet Corporation.

What is the FDA product code for Innova Nasal Non-Vented Mask?

The FDA product code for Innova Nasal Non-Vented Mask is BZD.

Other Devices by Sleepnet Corporation

K190533Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented K190254Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask K211274iQ 2 Nasal Mask, Phantom 2 Nasal Mask K241830Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask K241943Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask K241661Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask

View all 10 devices →

Related Devices (Code: BZD)

K160836Menai SystemResmed, Ltd. K161978AirFit N20Resmed, Ltd. K160127iCodeConnect3B Medical, Inc. K153505F&P Eson 2 Nasal MaskFisher & Paykel Healthcare Limited K160822S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASVResmed, Ltd. K153387Luna CPAP and Auto CPAP System3B Medical, 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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