The following data is part of a premarket notification filed by A & D Engineering, Inc. with the FDA for Takeda Medical Digital Sphygmomanometer/ Ua-741.
Device ID | K872629 |
510k Number | K872629 |
Device Name: | TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER/ UA-741 |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | A & D ENGINEERING, INC. P.O. BOX 32427 San Jose, CA 95152 |
Contact | Kimio Shibata |
Correspondent | Kimio Shibata A & D ENGINEERING, INC. P.O. BOX 32427 San Jose, CA 95152 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-06 |
Decision Date | 1987-09-15 |