The following data is part of a premarket notification filed by Advanced Medical Instruments, Inc. with the FDA for System 7300 Pulse Oximeter.
| Device ID | K910521 |
| 510k Number | K910521 |
| Device Name: | SYSTEM 7300 PULSE OXIMETER |
| Classification | Oximeter |
| 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 | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-07 |
| Decision Date | 1991-04-18 |