BPAP System
K-Number: K213169 · 2022-12-05
ApplicantBMC Medical Co., Ltd.
Decision Date2022-12-05
Product CodeMNS
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
BPAP System is a medical device manufactured by BMC Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-12-05 under approval number K213169. The device is classified under product code MNS. It was reviewed by the AN advisory panel. Product code MNS falls under the category of Neurology, which encompasses devices for neurological diagnosis and monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BPAP System?
BPAP System is a medical device that received FDA 510(k) clearance on 2022-12-05. It is manufactured by BMC Medical Co., Ltd.. The 510(k) number is K213169.
When was BPAP System approved by the FDA?
BPAP System received FDA 510(k) clearance on 2022-12-05, under approval number K213169.
What company makes BPAP System?
BPAP System is manufactured by BMC Medical Co., Ltd..
What is the FDA product code for BPAP System?
The FDA product code for BPAP System is MNS. This falls under the Neurology category.
Other Devices by BMC Medical Co., Ltd.
Related Devices (Code: MNS)
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.