The following data is part of a premarket notification filed by Ld Technology Llc with the FDA for Ld-oxi System.
Device ID | K160956 |
510k Number | K160956 |
Device Name: | LD-Oxi System |
Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
Applicant | LD TECHNOLOGY LLC 100N. Biscayne Blvd, Suite 500 Miami, FL 33132 |
Contact | Albert Maarek |
Correspondent | Albert Maarek LD TECHNOLOGY LLC 100N. Biscayne Blvd, Suite 500 Miami, FL 33132 |
Product Code | MWI |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-04-05 |
Decision Date | 2016-07-06 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B322D0011 | K160956 | 000 |