The following data is part of a premarket notification filed by Kodon(tianjin)electronic&electrical Apparatus Co., with the FDA for Kd-726 Memory Wrist Automatic Electronic Blood Pressure Monitor.
Device ID | K030359 |
510k Number | K030359 |
Device Name: | KD-726 MEMORY WRIST AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., NO.31, CHANGJIANG ROAD, NANKAI DISTRICT Tianjin, CN 300193 |
Contact | Liu Yi |
Correspondent | Liu Yi KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., NO.31, CHANGJIANG ROAD, NANKAI DISTRICT Tianjin, CN 300193 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-02-03 |
Decision Date | 2003-11-06 |
Summary: | summary |