FDA Product Code BSZ: Gas-machine, Anesthesia
Leading manufacturers include Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Datex-Ohmeda, Inc. and Codonics.Incorporated.
FDA 510(k) Cleared Gas-machine, Anesthesia Devices (Product Code BSZ)
About Product Code BSZ - Regulatory Context
510(k) Submission Activity
187 total 510(k) submissions under product code BSZ since 1976, with 187 receiving FDA clearance (average review time: 146 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA Review Time
Recent submissions under BSZ have taken an average of 72 days to reach a decision - down from 146 days historically, suggesting improved FDA processing for this classification.
BSZ devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →