The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Idoc Upper Arm Attached Blood Pressure And Pulse Rate Monitor, Model Id-42a/id-43a.
Device ID | K052872 |
510k Number | K052872 |
Device Name: | IDOC UPPER ARM ATTACHED BLOOD PRESSURE AND PULSE RATE MONITOR, MODEL ID-42A/ID-43A |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | TaiDoc Technology Corporation 4F, 88, SEC.1, KWANG FU ROAD San Chung, Taipei, TW 241 |
Contact | Shu-mei Wu |
Correspondent | Shu-mei Wu TaiDoc Technology Corporation 4F, 88, SEC.1, KWANG FU ROAD San Chung, Taipei, TW 241 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-10-11 |
Decision Date | 2005-11-23 |
Summary: | summary |