F&P Eson 2 Nasal Mask
K-Number: K153505 · 2016-09-20
ApplicantFisher & Paykel Healthcare Limited
Decision Date2016-09-20
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
F&P Eson 2 Nasal Mask is a medical device manufactured by Fisher & Paykel Healthcare Limited. It received FDA 510(k) clearance on 2016-09-20 under approval number K153505. 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 F&P Eson 2 Nasal Mask?
F&P Eson 2 Nasal Mask is a medical device that received FDA 510(k) clearance on 2016-09-20. It is manufactured by Fisher & Paykel Healthcare Limited. The 510(k) number is K153505.
When was F&P Eson 2 Nasal Mask approved by the FDA?
F&P Eson 2 Nasal Mask received FDA 510(k) clearance on 2016-09-20, under approval number K153505.
What company makes F&P Eson 2 Nasal Mask?
F&P Eson 2 Nasal Mask is manufactured by Fisher & Paykel Healthcare Limited.
What is the FDA product code for F&P Eson 2 Nasal Mask?
The FDA product code for F&P Eson 2 Nasal Mask is BZD.
Other Devices by Fisher & Paykel Healthcare Limited
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.