The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Gas Module 3.
| Device ID | K180788 |
| 510k Number | K180788 |
| Device Name: | Gas Module 3 |
| Classification | Spirometer, Monitoring (w/wo Alarm) |
| Applicant | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD Mindray Building, Keji 12th Road South High-tech Industrial Park, Nanshan Shenzhen, CN 518057 |
| Contact | Yanhong Bai |
| Correspondent | Yanhong Bai SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD Mindray Building, Keji 12th Road South High-tech Industrial Park, Nanshan Shenzhen, CN 518057 |
| Product Code | BZK |
| CFR Regulation Number | 868.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-26 |
| Decision Date | 2018-10-24 |
| Summary: | summary |