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 |