Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)
K-Number: K163464 · 2017-09-05
ApplicantBmc Medical., Ltd.
Decision Date2017-09-05
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) is a medical device manufactured by Bmc Medical., Ltd.. It received FDA 510(k) clearance on 2017-09-05 under approval number K163464. 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 Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)?
Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) is a medical device that received FDA 510(k) clearance on 2017-09-05. It is manufactured by Bmc Medical., Ltd.. The 510(k) number is K163464.
When was Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) approved by the FDA?
Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) received FDA 510(k) clearance on 2017-09-05, under approval number K163464.
What company makes Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)?
Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) is manufactured by Bmc Medical., Ltd..
What is the FDA product code for Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)?
The FDA product code for Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) 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.