The following data is part of a premarket notification filed by Beijing Choice Electronic Technololgy Co., Ltd. with the FDA for Fingertip Pulse Oximeter, Model Md300ca Nd300ca.
Device ID | K092652 |
510k Number | K092652 |
Device Name: | FINGERTIP PULSE OXIMETER, MODEL MD300CA ND300CA |
Classification | Oximeter |
Applicant | BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. BAILANGUYAN BLDG B 1127-1128 FUXING RD, A36 Beijing, CN 100039 |
Contact | Lei Chen |
Correspondent | Lei Chen BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. BAILANGUYAN BLDG B 1127-1128 FUXING RD, A36 Beijing, CN 100039 |
Product Code | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-08-28 |
Decision Date | 2010-01-08 |
Summary: | summary |