The following data is part of a premarket notification filed by Marquette Medical Systems, Inc. with the FDA for Apex Oximeter.
| Device ID | K980299 |
| 510k Number | K980299 |
| Device Name: | APEX OXIMETER |
| Classification | Oximeter |
| Applicant | MARQUETTE MEDICAL SYSTEMS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | David Wahlig |
| Correspondent | David Wahlig MARQUETTE MEDICAL SYSTEMS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-27 |
| Decision Date | 1998-04-24 |
| Summary: | summary |