K043520 is an FDA 510(k) clearance for the EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR. This device is classified as a Generator, Oxygen, Portable (Class II - Special Controls, product code CAW).
Submitted by Emg Technology Co., Ltd. (Baltimore, US). The FDA issued a Cleared decision on October 21, 2005, 305 days after receiving the submission on December 20, 2004.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5440.
| 510(k) Number | K043520 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2004 |
| Decision Date | October 21, 2005 |
| Days to Decision | 305 days |
| Submission Type | Abbreviated |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | CAW — Generator, Oxygen, Portable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5440 |