The following data is part of a premarket notification filed by A & D Engineering, Inc. with the FDA for Takeda Medical Auto. Ambu. Blood Press. Meter/2420.
Device ID | K880079 |
510k Number | K880079 |
Device Name: | TAKEDA MEDICAL AUTO. AMBU. BLOOD PRESS. METER/2420 |
Classification | Computer, Blood-pressure |
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 | DSK |
CFR Regulation Number | 870.1110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-01-11 |
Decision Date | 1988-03-31 |