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FDA 510(k)

SleepWeaver 3D Nasal Mask

K-Number: K162905 · 2017-03-15

ApplicantCircadiance, LLC
Decision Date2017-03-15
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SleepWeaver 3D Nasal Mask is a medical device manufactured by Circadiance, LLC. It received FDA 510(k) clearance on 2017-03-15 under approval number K162905. 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 SleepWeaver 3D Nasal Mask?

SleepWeaver 3D Nasal Mask is a medical device that received FDA 510(k) clearance on 2017-03-15. It is manufactured by Circadiance, LLC. The 510(k) number is K162905.

When was SleepWeaver 3D Nasal Mask approved by the FDA?

SleepWeaver 3D Nasal Mask received FDA 510(k) clearance on 2017-03-15, under approval number K162905.

What company makes SleepWeaver 3D Nasal Mask?

SleepWeaver 3D Nasal Mask is manufactured by Circadiance, LLC.

What is the FDA product code for SleepWeaver 3D Nasal Mask?

The FDA product code for SleepWeaver 3D Nasal Mask is BZD.

Other Devices by Circadiance, LLC

K151683SleepWeaver Advance Pediatric Nasal CPAP Mask

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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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