The following data is part of a premarket notification filed by Mediaid Inc. with the FDA for Mediaid Disposable Non-adhesive Sensors, Model Cst050-2101n; Reusable Finger Clip Sp02 Sensors, Model Cst060-2101n.
Device ID | K061896 |
510k Number | K061896 |
Device Name: | MEDIAID DISPOSABLE NON-ADHESIVE SENSORS, MODEL CST050-2101N; REUSABLE FINGER CLIP SP02 SENSORS, MODEL CST060-2101N |
Classification | Oximeter |
Applicant | MEDIAID INC. 17517 FABRICA WAY #H Cerritos, CA 90703 |
Contact | Mahesh Patel |
Correspondent | Mahesh Patel MEDIAID INC. 17517 FABRICA WAY #H Cerritos, CA 90703 |
Product Code | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-07-03 |
Decision Date | 2007-04-12 |
Summary: | summary |