K014301 is an FDA 510(k) clearance for the MODIFICATION TO 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. (Fort Myers, US). The FDA issued a Cleared decision on February 11, 2002, 42 days after receiving the submission on December 31, 2001.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5440.
| 510(k) Number | K014301 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 31, 2001 |
| Decision Date | February 11, 2002 |
| Days to Decision | 42 days |
| Submission Type | Special |
| 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 |