The following data is part of a premarket notification filed by Merits Health Products Co., Ltd. with the FDA for Merits Health Products Portable Nebulizer.
| Device ID | K053490 |
| 510k Number | K053490 |
| Device Name: | MERITS HEALTH PRODUCTS PORTABLE NEBULIZER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | MERITS HEALTH PRODUCTS CO., LTD. 9, ROAD 36 TAICHUNG INDUSTRIAL PARK Taichung, TW 407 |
| Contact | Steve Chao |
| Correspondent | Steve Chao MERITS HEALTH PRODUCTS CO., LTD. 9, ROAD 36 TAICHUNG INDUSTRIAL PARK Taichung, TW 407 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-15 |
| Decision Date | 2006-07-24 |
| Summary: | summary |