The following data is part of a premarket notification filed by Beijing M&b Electronic Instruments Co., Ltd. with the FDA for Msa100bt Peak Flow Meter.
| Device ID | K170281 |
| 510k Number | K170281 |
| Device Name: | MSA100BT Peak Flow Meter |
| Classification | Meter, Peak Flow, Spirometry |
| Applicant | Beijing M&B Electronic Instruments Co., Ltd. No. 27, Yongwang Road, Daxing Bioengineering And Medicine Industry Base Beijing, CN 101102 |
| Contact | Yang Shisheng |
| Correspondent | Mike Gu Guangzhou Osmunda Medical Device Technical Services Co.,Ltd. 8-9Th Floor, R&D Building, No.26 Qinglan St, Panyu District Guangzhou, CN 510006 |
| Product Code | BZH |
| CFR Regulation Number | 868.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-30 |
| Decision Date | 2017-10-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00146191010005 | K170281 | 000 |
| 04897100310162 | K170281 | 000 |