AF531 Oro-Nasal SE Face Mask
K-Number: K243394 · 2024-12-30
ApplicantRespironics, Inc.
Decision Date2024-12-30
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
AF531 Oro-Nasal SE Face Mask is a medical device manufactured by Respironics, Inc.. It received FDA 510(k) clearance on 2024-12-30 under approval number K243394. 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 AF531 Oro-Nasal SE Face Mask?
AF531 Oro-Nasal SE Face Mask is a medical device that received FDA 510(k) clearance on 2024-12-30. It is manufactured by Respironics, Inc.. The 510(k) number is K243394.
When was AF531 Oro-Nasal SE Face Mask approved by the FDA?
AF531 Oro-Nasal SE Face Mask received FDA 510(k) clearance on 2024-12-30, under approval number K243394.
What company makes AF531 Oro-Nasal SE Face Mask?
AF531 Oro-Nasal SE Face Mask is manufactured by Respironics, Inc..
What is the FDA product code for AF531 Oro-Nasal SE Face Mask?
The FDA product code for AF531 Oro-Nasal SE Face Mask is CBK.
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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.