The following data is part of a premarket notification filed by Merits Health Products Co., Ltd. with the FDA for Merits Health Products Oxygen Concentrators.
| Device ID | K053230 |
| 510k Number | K053230 |
| Device Name: | MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS |
| Classification | Generator, Oxygen, Portable |
| 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 | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-18 |
| Decision Date | 2006-05-16 |
| Summary: | summary |