Spirometer
Spirometer, Diagnostic
MeHow Innovative Ltd
The following data is part of a premarket notification filed by Mehow Innovative Ltd with the FDA for Spirometer.
Pre-market Notification Details
| Device ID | K201493 |
| 510k Number | K201493 |
| Device Name: | Spirometer |
| Classification | Spirometer, Diagnostic |
| Applicant | MeHow Innovative Ltd Block A&B&C, NCBC Industrial Park, 6th Baolong Road, Longgang District Shenzhen, CN 518116 |
| Contact | Gloria Sun |
| Correspondent | Olivia Meng Guangzhou Osmunda Medical Device Technical Service Co., Ltd 8-9th Floor, R&D Building, No.26 Qinglan Street, Panyu District Guangzhou, CN 510006 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-04 |
| Decision Date | 2021-06-10 |
Trademark Results [Spirometer]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPIROMETER 73123579 1097926 Dead/Expired |
AMCHEM PRODUCTS, INC. 1977-04-21 |
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