The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Oxisat.
Device ID | K934091 |
510k Number | K934091 |
Device Name: | OXISAT |
Classification | Oximeter |
Applicant | MARQUETTE ELECTRONICS, INC. 100 MARQUETTE DR. Jupiter, FL 33468 |
Contact | Michael T Laughran |
Correspondent | Michael T Laughran 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 | 1993-08-23 |
Decision Date | 1994-03-15 |