The following data is part of a premarket notification filed by Advanced Medical Instruments, Inc. with the FDA for System 7100 Non-invasive Blood Pressure Monitor.
| Device ID | K897173 |
| 510k Number | K897173 |
| Device Name: | SYSTEM 7100 NON-INVASIVE BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | ADVANCED MEDICAL INSTRUMENTS, INC. 3061 WEST ALBANY Broken Arrow, OK 74012 |
| Contact | James Lalicker |
| Correspondent | James Lalicker ADVANCED MEDICAL INSTRUMENTS, INC. 3061 WEST ALBANY Broken Arrow, OK 74012 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-27 |
| Decision Date | 1990-10-23 |