510(k) K180788
K180788 is an FDA 510(k) premarket notification submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. for the device "Gas Module 3". The FDA issued a decision of Substantially Equivalent on October 24, 2018. The device falls under product code BZK (Spirometer, Monitoring (W/Wo Alarm)), a Class II device regulated under 21 CFR 868.1850. Shenzhen Mindray Bio-Medical Electronics Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 24, 2018
- Date Received
- March 26, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spirometer, Monitoring (W/Wo Alarm)
- Device Class
- Class II
- Regulation Number
- 868.1850
- Review Panel
- AN
- Submission Type