The following data is part of a premarket notification filed by Emg Technology Co., Ltd. with the FDA for Emg Ac/dc Suction Unit.
| Device ID | K063448 |
| 510k Number | K063448 |
| Device Name: | EMG AC/DC SUCTION UNIT |
| Classification | Apparatus, Suction, Ward Use, Portable, Ac-powered |
| Applicant | EMG TECHNOLOGY CO., LTD. 4F-2, NO. 210, 38 RD. TAICHUNG INDUSTRIAL PARK Shituen Chiu, Taichung, TW 40768 |
| Contact | Sally Chuang |
| Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | JCX |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-11-15 |
| Decision Date | 2006-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840117326576 | K063448 | 000 |