The following data is part of a premarket notification filed by Beijing M&b Electronic Instruments, Co., Ltd with the FDA for Msa100 Peak Flow Meter.
| Device ID | K133975 |
| 510k Number | K133975 |
| Device Name: | MSA100 PEAK FLOW METER |
| Classification | Meter, Peak Flow, Spirometry |
| Applicant | BEIJING M&B ELECTRONIC INSTRUMENTS, CO., LTD 7TH FLOOR, JINGUI BUSINESS BUILDING, NO.982 CONGYUN RD BAIYUN DISTRICT Guangzhou, Guangdong, CN 510420 |
| Contact | Mike Gu |
| Correspondent | Mike Gu BEIJING M&B ELECTRONIC INSTRUMENTS, CO., LTD 7TH FLOOR, JINGUI BUSINESS BUILDING, NO.982 CONGYUN RD BAIYUN DISTRICT Guangzhou, Guangdong, CN 510420 |
| Product Code | BZH |
| CFR Regulation Number | 868.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-26 |
| Decision Date | 2014-10-03 |
| Summary: | summary |