The following data is part of a premarket notification filed by Shanghai Kodea Economic And Trade Development Ltd. with the FDA for Kodea, Models Xj-2001ac; Xj-2002as; Xj-2003a.
| Device ID | K062893 |
| 510k Number | K062893 |
| Device Name: | KODEA, MODELS XJ-2001AC; XJ-2002AS; XJ-2003A |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | SHANGHAI KODEA ECONOMIC AND TRADE DEVELOPMENT LTD. ROME. 902, NO.15, LANE 28, QINGJIANG ROAD Shanghai, CN 200233 |
| Contact | Zhao J Yu |
| Correspondent | Zhao J Yu SHANGHAI KODEA ECONOMIC AND TRADE DEVELOPMENT LTD. ROME. 902, NO.15, LANE 28, QINGJIANG ROAD Shanghai, CN 200233 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-27 |
| Decision Date | 2007-02-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815027010020 | K062893 | 000 |
| 00815027010013 | K062893 | 000 |
| 00815027010006 | K062893 | 000 |