The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Bs-800m/ Abs800/ba-800m Ise Kit, Bs-800m Chemistry Analyzer, Ba-800m Chemistry Analyzer, Abs800 Chemistry Analyzer.
| Device ID | K160370 |
| 510k Number | K160370 |
| Device Name: | BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD MINDRAY BUILDING, KEJI 12TH RD SOUTH, HI-TECH INDUSTRIAL PARK Shenzhen, CN 518057 |
| Contact | Zeng Zhe |
| Correspondent | Zeng Zhe SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD MINDRAY BUILDING, KEJI 12TH RD SOUTH, HI-TECH INDUSTRIAL PARK Shenzhen, CN 518057 |
| Product Code | JGS |
| Subsequent Product Code | CDQ |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | JJE |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-10 |
| Decision Date | 2016-06-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944904084985 | K160370 | 000 |
| 06944904024622 | K160370 | 000 |
| 06944904024639 | K160370 | 000 |
| 06944904024646 | K160370 | 000 |
| 06944904026565 | K160370 | 000 |
| 06944904067865 | K160370 | 000 |
| 06944904084466 | K160370 | 000 |
| 06944904084572 | K160370 | 000 |
| 06944904084589 | K160370 | 000 |
| 06944904084596 | K160370 | 000 |
| 06944904084602 | K160370 | 000 |
| 06944904084961 | K160370 | 000 |
| 06944904084978 | K160370 | 000 |
| 06944904024615 | K160370 | 000 |