The following data is part of a premarket notification filed by Shenzhen Aeon Technology Co., Ltd. with the FDA for Pulse Oximeter.
Device ID | K190869 |
510k Number | K190869 |
Device Name: | Pulse Oximeter |
Classification | Oximeter |
Applicant | Shenzhen Aeon Technology Co., Ltd. RM6H02, Block 27-29, Tianxia IC Industrial Park, Majialong No.133 Of Yiyuan Road, Nantou Street, Nanshan District Shenzhen, CN 518052 |
Contact | Xie Hua |
Correspondent | Kevin Wang Chonconn Medical Device Consulting Co., Ltd. No. A415, Block A, NanShan Medical Devices Industrial Park Nanshan District Shenzhen, CN 518067 |
Product Code | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-04-03 |
Decision Date | 2019-09-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
36947832500375 | K190869 | 000 |
08719699634480 | K190869 | 000 |
46947832500372 | K190869 | 000 |
36947832500085 | K190869 | 000 |
36947832500108 | K190869 | 000 |
36947832500115 | K190869 | 000 |
36947832500122 | K190869 | 000 |
36947832500306 | K190869 | 000 |
36947832500351 | K190869 | 000 |
36947832500368 | K190869 | 000 |
46947832500099 | K190869 | 000 |