The following data is part of a premarket notification filed by Emg Technology Co., Ltd. with the FDA for Emg Triton -comp,model Nca01-xxx Series.
Device ID | K072634 |
510k Number | K072634 |
Device Name: | EMG TRITON -COMP,MODEL NCA01-XXX SERIES |
Classification | Compressor, Air, Portable |
Applicant | EMG TECHNOLOGY CO., LTD. 4F-2, NO. 210, 38 RD. TAICHUNG INDUSTRIAL PARK Shituen Chiu, Taichung, TW 40768 |
Contact | Sally Chuang |
Correspondent | Casey Conry UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
Product Code | BTI |
CFR Regulation Number | 868.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2007-09-18 |
Decision Date | 2008-11-19 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00260720011711 | K072634 | 000 |
00822383115054 | K072634 | 000 |
00841447104278 | K072634 | 000 |
00026072011713 | K072634 | 000 |
00840117324008 | K072634 | 000 |