DreamWear Silicone Pillows Mask
K-Number: K210844 · 2021-08-24
ApplicantRespironics, Inc.
Decision Date2021-08-24
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
DreamWear Silicone Pillows Mask is a medical device manufactured by Respironics, Inc.. It received FDA 510(k) clearance on 2021-08-24 under approval number K210844. 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 DreamWear Silicone Pillows Mask?
DreamWear Silicone Pillows Mask is a medical device that received FDA 510(k) clearance on 2021-08-24. It is manufactured by Respironics, Inc.. The 510(k) number is K210844.
When was DreamWear Silicone Pillows Mask approved by the FDA?
DreamWear Silicone Pillows Mask received FDA 510(k) clearance on 2021-08-24, under approval number K210844.
What company makes DreamWear Silicone Pillows Mask?
DreamWear Silicone Pillows Mask is manufactured by Respironics, Inc..
What is the FDA product code for DreamWear Silicone Pillows Mask?
The FDA product code for DreamWear Silicone Pillows Mask is BZD.
Other Devices by Respironics, Inc.
Related Devices (Code: BZD)
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.