TBL-ABI System
510(k) K173696
TBL-ABI System is a Class II device made by Ld Technology, LLC, cleared under FDA 510(k) K173696 on 19 Dec 2017, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK173696 | Date19 Dec 2017 | StatusActive |
Official records
- FDA 510(k) database K173696
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JOM
- Device class
- Class II
- Regulation
- 21 CFR Part 870.2780
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K173696
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| TBL-ABI C001 | C001 | B322C0011 | — | On the market |
Similar devices
Other devices filed under FDA product code JOM (Plethysmograph, Photoelectric, Pneumatic Or Hydraulic).
- Biomedix Padnet Lab by BIOMEDIX-INC
- Pulse Cuff Recorder Model PCR100 by Imex Medical Systems, Inc.
- 3D Vascular Recorder by D. E. Hokanson, Inc.
- PADNET+ by BIOMEDIX-INC
- OSM-1 Oxygen Saturation Monitor by Criticare Systems, Inc.
- Phlebotest 2000 by Osborn Medical Corp.
- VENOMETER by Advanced Medical Technology, Inc.
- PVR-100/VASOGRAM by Vasocor, Inc.
- DIGITMATIC DM2 by Medimatic
- VASOPULSE(TM)/MODEL 5000 by Sonicaid, Inc.