The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Marquette Ear Probe Sensor.
Device ID | K942752 |
510k Number | K942752 |
Device Name: | MARQUETTE EAR PROBE SENSOR |
Classification | Oximeter, Ear |
Applicant | MARQUETTE ELECTRONICS, INC. 100 MARQUETTE DR. Jupiter, FL 33468 |
Contact | Michael Laughran |
Correspondent | Michael Laughran MARQUETTE ELECTRONICS, INC. 100 MARQUETTE DR. Jupiter, FL 33468 |
Product Code | DPZ |
CFR Regulation Number | 870.2710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-06-10 |
Decision Date | 1994-09-02 |