The following data is part of a premarket notification filed by Emg Technology Co., Ltd. with the FDA for Emg Model Sua01 Suction Unit.
Device ID | K042349 |
510k Number | K042349 |
Device Name: | EMG MODEL SUA01 SUCTION UNIT |
Classification | Apparatus, Suction, Ward Use, Portable, Ac-powered |
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 | JCX |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-08-30 |
Decision Date | 2004-12-16 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00260720011674 | K042349 | 000 |
00026072011676 | K042349 | 000 |
00026072011669 | K042349 | 000 |
00026072011652 | K042349 | 000 |
00026072011645 | K042349 | 000 |
00026072011638 | K042349 | 000 |
00026072011621 | K042349 | 000 |
00026072011614 | K042349 | 000 |
10080196045785 | K042349 | 000 |
40080196769293 | K042349 | 000 |
M368S1311 | K042349 | 000 |
00840117309623 | K042349 | 000 |
00822383228693 | K042349 | 000 |
00616784082011 | K042349 | 000 |
00616784082110 | K042349 | 000 |
00260720011667 | K042349 | 000 |
00260720011650 | K042349 | 000 |
00260720011643 | K042349 | 000 |
00260720011636 | K042349 | 000 |
00260720011629 | K042349 | 000 |
00260720011612 | K042349 | 000 |
00822383971360 | K042349 | 000 |
00822383519024 | K042349 | 000 |
00822383111377 | K042349 | 000 |
00841447104261 | K042349 | 000 |
50822383286568 | K042349 | 000 |
00840117309609 | K042349 | 000 |