The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for A7 Anesthesia System.
Device ID | K142552 |
510k Number | K142552 |
Device Name: | A7 Anesthesia System |
Classification | Gas-machine, Anesthesia |
Applicant | ShenZhen Mindray Bio-Medical Electronics Co., Ltd Mindray Building, Keji 12th Road South High-tech Industrial Park, Nanshan Shenzhen, CN 518057 |
Contact | Tang Hao |
Correspondent | Tang Hao ShenZhen Mindray Bio-Medical Electronics Co., Ltd Mindray Building, Keji 12th Road South High-tech Industrial Park, Nanshan Shenzhen, CN 518057 |
Product Code | BSZ |
CFR Regulation Number | 868.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-09-10 |
Decision Date | 2015-01-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06944904039695 | K142552 | 000 |