K053230 is an FDA 510(k) clearance for the MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS. This device is classified as a Generator, Oxygen, Portable (Class II - Special Controls, product code CAW).
Submitted by Merits Health Products Co., Ltd. (Taichung, TW). The FDA issued a Cleared decision on May 16, 2006, 179 days after receiving the submission on November 18, 2005.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5440.
| 510(k) Number | K053230 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 2005 |
| Decision Date | May 16, 2006 |
| Days to Decision | 179 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CAW - Generator, Oxygen, Portable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5440 |