Therapy Mask 3100 NC/SP
K-Number: K231313 · 2023-07-28
ApplicantRespironics, Inc.
Decision Date2023-07-28
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Therapy Mask 3100 NC/SP is a medical device manufactured by Respironics, Inc.. It received FDA 510(k) clearance on 2023-07-28 under approval number K231313. 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 Therapy Mask 3100 NC/SP?
Therapy Mask 3100 NC/SP is a medical device that received FDA 510(k) clearance on 2023-07-28. It is manufactured by Respironics, Inc.. The 510(k) number is K231313.
When was Therapy Mask 3100 NC/SP approved by the FDA?
Therapy Mask 3100 NC/SP received FDA 510(k) clearance on 2023-07-28, under approval number K231313.
What company makes Therapy Mask 3100 NC/SP?
Therapy Mask 3100 NC/SP is manufactured by Respironics, Inc..
What is the FDA product code for Therapy Mask 3100 NC/SP?
The FDA product code for Therapy Mask 3100 NC/SP 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.