The following data is part of a premarket notification filed by Emg Technology Co., Ltd. with the FDA for Emg Suction Unit.
| Device ID | K112421 |
| 510k Number | K112421 |
| Device Name: | EMG SUCTION UNIT |
| Classification | Apparatus, Suction, Ward Use, Portable, Ac-powered |
| Applicant | EMG TECHNOLOGY CO., LTD. NO.58, 35 RD, TAICHUNG INDUSTRIAL PARK, SHITUEN CHIU Taichung, TW 40768 |
| Contact | Paul Cho |
| Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | JCX |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-08-23 |
| Decision Date | 2011-09-01 |
| Summary: | summary |