The following data is part of a premarket notification filed by Emg Technology Co., Ltd. with the FDA for Emg Handle Nebulizer Nb02 Series.
| Device ID | K052438 |
| 510k Number | K052438 |
| Device Name: | EMG HANDLE NEBULIZER NB02 SERIES |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | EMG TECHNOLOGY CO., LTD. 98 STANTON STREET Wilkes Barre, PA 18702 |
| Contact | Gene R Kulon |
| Correspondent | Gene R Kulon EMG TECHNOLOGY CO., LTD. 98 STANTON STREET Wilkes Barre, PA 18702 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-06 |
| Decision Date | 2006-01-31 |