The following data is part of a premarket notification filed by A & D Engineering, Inc. with the FDA for Takeda Medical Auto. Digital Blood Pres. Monitor.
| Device ID | K882824 |
| 510k Number | K882824 |
| Device Name: | TAKEDA MEDICAL AUTO. DIGITAL BLOOD PRES. MONITOR |
| 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 | 1988-07-08 |
| Decision Date | 1989-01-17 |