The following data is part of a premarket notification filed by Suzhou Weikang Medical Apparatus Co., Ltd with the FDA for Disposable Nebulizer Set.
Device ID | K140237 |
510k Number | K140237 |
Device Name: | DISPOSABLE NEBULIZER SET |
Classification | Nebulizer (direct Patient Interface) |
Applicant | SUZHOU WEIKANG MEDICAL APPARATUS CO., LTD 7TH FL. JINGUI BUSINESS BUIDLING NO. 982 CONGYUN RD, BAIYUN DISTRICT Guangzhou, Guangdong, CN 510420 |
Contact | Mike Gu |
Correspondent | Mike Gu SUZHOU WEIKANG MEDICAL APPARATUS CO., LTD 7TH FL. JINGUI BUSINESS BUIDLING NO. 982 CONGYUN RD, BAIYUN DISTRICT Guangzhou, Guangdong, CN 510420 |
Product Code | CAF |
CFR Regulation Number | 868.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-01-30 |
Decision Date | 2015-01-08 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
40612479231670 | K140237 | 000 |
00616784560731 | K140237 | 000 |
00616784561738 | K140237 | 000 |
10850005165108 | K140237 | 000 |
10850005165092 | K140237 | 000 |
10850005165085 | K140237 | 000 |
10850005165078 | K140237 | 000 |