The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Marquette Adult/neonatal Wrap Sensor.
| Device ID | K943817 |
| 510k Number | K943817 |
| Device Name: | MARQUETTE ADULT/NEONATAL WRAP SENSOR |
| Classification | Oximeter |
| Applicant | MARQUETTE ELECTRONICS, INC. 100 MARQUETTE DR. Jupiter, FL 33468 |
| Contact | David A Lovejoy |
| Correspondent | David A Lovejoy MARQUETTE ELECTRONICS, INC. 100 MARQUETTE DR. Jupiter, FL 33468 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-05 |
| Decision Date | 1994-10-18 |