The following data is part of a premarket notification filed by Merits Health Products Co., Ltd. with the FDA for Merits Health Products Oxygen Concentrator.
| Device ID | K050430 |
| 510k Number | K050430 |
| Device Name: | MERITS HEALTH PRODUCTS OXYGEN CONCENTRATOR |
| Classification | Generator, Oxygen, Portable |
| Applicant | MERITS HEALTH PRODUCTS CO., LTD. 7690 CAMERON CIRCLE Fort Myers, FL 33912 |
| Contact | Lee Leichter |
| Correspondent | Lee Leichter MERITS HEALTH PRODUCTS CO., LTD. 7690 CAMERON CIRCLE Fort Myers, FL 33912 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-18 |
| Decision Date | 2005-08-04 |
| Summary: | summary |