The following data is part of a premarket notification filed by Emg Technology Co., Ltd. with the FDA for Emg Cta01-xxx Series Puro Oxygen Concentrator.
| Device ID | K043520 |
| 510k Number | K043520 |
| Device Name: | EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR |
| Classification | Generator, Oxygen, Portable |
| Applicant | EMG TECHNOLOGY CO., LTD. 914 WEST PATAPSCO AVE. Baltimore, MD 21230 |
| Contact | Leonard Frier |
| Correspondent | Leonard Frier EMG TECHNOLOGY CO., LTD. 914 WEST PATAPSCO AVE. Baltimore, MD 21230 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-20 |
| Decision Date | 2005-10-21 |