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 |