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 | K151954 |
| 510k Number | K151954 |
| Device Name: | A7 Anesthesia System |
| Classification | Gas-machine, Anesthesia |
| Applicant | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. MINDRAY BUILDING, KEJI 12TH ROAD SOUTH, HI-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, HI-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 | 2015-07-15 |
| Decision Date | 2015-10-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944904086828 | K151954 | 000 |
| 06944904084251 | K151954 | 000 |
| 06944904084190 | K151954 | 000 |