The following data is part of a premarket notification filed by Shanghai Sonmol Medical Equipment Co., Ltd. with the FDA for Peak Flow Meter.
| Device ID | K203196 |
| 510k Number | K203196 |
| Device Name: | Peak Flow Meter |
| Classification | Meter, Peak Flow, Spirometry |
| Applicant | Shanghai Sonmol Medical Equipment Co., Ltd. Room 116-118, Building 21,No.500 Jiajian Road, Jiading District Shanghai, CN |
| Contact | Li Yong Xu |
| Correspondent | Raymond Luo Shanghai Sungo Management Consulting Company Limited 14th F, 1500# Century Avenue Shanghai, CN 200122 |
| Product Code | BZH |
| CFR Regulation Number | 868.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-28 |
| Decision Date | 2021-05-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06975038051017 | K203196 | 000 |