Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Auto CPAP System

K-Number: K211155 · 2022-03-09

Decision Date2022-03-09
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Auto CPAP System is a medical device manufactured by BMC Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-03-09 under approval number K211155. 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 Auto CPAP System?

Auto CPAP System is a medical device that received FDA 510(k) clearance on 2022-03-09. It is manufactured by BMC Medical Co., Ltd.. The 510(k) number is K211155.

When was Auto CPAP System approved by the FDA?

Auto CPAP System received FDA 510(k) clearance on 2022-03-09, under approval number K211155.

What company makes Auto CPAP System?

Auto CPAP System is manufactured by BMC Medical Co., Ltd..

What is the FDA product code for Auto CPAP System?

The FDA product code for Auto CPAP System is BZD.

Other Devices by BMC Medical Co., Ltd.

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.