The following data is part of a premarket notification filed by Guangzhou Homesun Medical Technology Co., Ltd with the FDA for Smart Peak Flow Meter.
| Device ID | K191239 |
| 510k Number | K191239 |
| Device Name: | Smart Peak Flow Meter |
| Classification | Meter, Peak Flow, Spirometry |
| Applicant | Guangzhou Homesun Medical Technology Co., Ltd Floor 7th, TianxiangBusiness Building, No.28, Li Fu Road, Haizhu District Guangzhou, CN 510250 |
| Contact | Jinqun Li |
| Correspondent | Tracy Che Feiying Drug & Medical Consulting Technical Service Group B-3F 3005, Bldg.1, Southward Ruifeng Business Center, No. 22 Guimiao Rd. Shenzhen, CN 518000 |
| Product Code | BZH |
| CFR Regulation Number | 868.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-08 |
| Decision Date | 2019-12-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970397220012 | K191239 | 000 |