The following data is part of a premarket notification filed by Ld Technology Llc with the FDA for Tbl-abi System.
Device ID | K173696 |
510k Number | K173696 |
Device Name: | TBL-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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-12-01 |
Decision Date | 2017-12-19 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B322C0011 | K173696 | 000 |