The following data is part of a premarket notification filed by Emg Technology Co., Ltd. with the FDA for Compressor Nebulizer, Model Emg Nba02-xxx Series.
| Device ID | K043238 |
| 510k Number | K043238 |
| Device Name: | COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES |
| Classification | Nebulizer (direct Patient Interface) |
| 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 | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-22 |
| Decision Date | 2005-07-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40260720011702 | K043238 | 000 |
| 00840117300019 | K043238 | 000 |
| 00841447108030 | K043238 | 000 |
| 00841447108023 | K043238 | 000 |
| 00841447108016 | K043238 | 000 |
| 00026072011706 | K043238 | 000 |
| 00026072011683 | K043238 | 000 |
| 00026072011690 | K043238 | 000 |
| 00840117308794 | K043238 | 000 |
| 00840117308763 | K043238 | 000 |
| 00840117300026 | K043238 | 000 |
| 00372217005032 | K043238 | 000 |
| 40260720011696 | K043238 | 000 |
| 40260720011689 | K043238 | 000 |
| 50096295128791 | K043238 | 000 |
| 50096295128784 | K043238 | 000 |
| 00845717007122 | K043238 | 000 |
| 10845717007112 | K043238 | 000 |
| 10841447104046 | K043238 | 000 |
| 00372217005056 | K043238 | 000 |
| 00372217005049 | K043238 | 000 |
| 00840117308732 | K043238 | 000 |