The following data is part of a premarket notification filed by A & D Engineering, Inc. with the FDA for Takeda Medical Blood Pressure Meter Model Tm-2610.
Device ID | K874338 |
510k Number | K874338 |
Device Name: | TAKEDA MEDICAL BLOOD PRESSURE METER MODEL TM-2610 |
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 | 1987-10-21 |
Decision Date | 1988-02-05 |