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 |