The following data is part of a premarket notification filed by Advanced Medical Instruments, Inc. with the FDA for Disp. Neonatal Blood Pressure Monitoring Cuff.
| Device ID | K896788 |
| 510k Number | K896788 |
| Device Name: | DISP. NEONATAL BLOOD PRESSURE MONITORING CUFF |
| Classification | Blood Pressure Cuff |
| 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 | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-04 |
| Decision Date | 1990-01-19 |