FDA Product Code BZK: Spirometer, Monitoring (w/wo Alarm)
Leading manufacturers include Respiratory Motion, Inc., Shenzhen Mindray Bio-Medical Electronics Co., Ltd. and Mermaid Care A/S.
61
Total
61
Cleared
107d
Avg days
1976
Since
FDA 510(k) Cleared Spirometer, Monitoring (w/wo Alarm) Devices (Product Code BZK)
61 devices
Cleared
Dec 18, 2019
BEACON Caresystem Model 00002144
Mermaid Care A/S
Anesthesiology
90d
Cleared
Dec 17, 2019
ExSpiron 2Xi
Respiratory Motion
Anesthesiology
88d
Cleared
Oct 24, 2018
Gas Module 3
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Anesthesiology
212d
Cleared
Mar 16, 2018
ExSpiron 1Xi
Respiratory Motion, Inc.
Anesthesiology
168d