The following data is part of a premarket notification filed by Ld Technology Llc with the FDA for Tm-abi System.
| Device ID | K143152 |
| 510k Number | K143152 |
| Device Name: | TM-ABI System |
| Classification | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| Applicant | LD TECHNOLOGY LLC 100 N. Biscayne Blvd., Suite 502 Miami, FL 33132 |
| Contact | Albert Maarek |
| Correspondent | Albert Maarek LD TECHNOLOGY LLC 100 N. Biscayne Blvd., Suite 502 Miami, FL 33132 |
| Product Code | JOM |
| CFR Regulation Number | 870.2780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-03 |
| Decision Date | 2015-07-22 |
| Summary: | summary |