The following data is part of a premarket notification filed by Apk Technology Co., Ltd with the FDA for Blood Pressure Cuff.
Device ID | K102825 |
510k Number | K102825 |
Device Name: | BLOOD PRESSURE CUFF |
Classification | Blood Pressure Cuff |
Applicant | APK TECHNOLOGY CO., LTD P.O. BOX 237-023 Shanghai, CN 518126 |
Contact | Diana Hong |
Correspondent | Diana Hong APK TECHNOLOGY CO., LTD P.O. BOX 237-023 Shanghai, CN 518126 |
Product Code | DXQ |
CFR Regulation Number | 870.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-09-29 |
Decision Date | 2011-03-02 |
Summary: | summary |