AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask
K-Number: K233555 · 2024-07-31
ApplicantPhilips Respironics
Decision Date2024-07-31
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask is a medical device manufactured by Philips Respironics. It received FDA 510(k) clearance on 2024-07-31 under approval number K233555. 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 AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask?
AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask is a medical device that received FDA 510(k) clearance on 2024-07-31. It is manufactured by Philips Respironics. The 510(k) number is K233555.
When was AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask approved by the FDA?
AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask received FDA 510(k) clearance on 2024-07-31, under approval number K233555.
What company makes AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask?
AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask is manufactured by Philips Respironics.
What is the FDA product code for AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask?
The FDA product code for AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask is BZD.
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.