TBL-ABI System
FDA 510(k) K173696 · Ld Technology, LLC
510(k) numberK173696
Submission
- Device name
- TBL-ABI System
- Applicant
- Ld Technology, LLC
Miami, FL, US - Received
- December 1, 2017
- Decision date
- December 19, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JOM – Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2780
- Specialty
- Cardiovascular
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| K140412 | ANS1 SoftwareDXN · Special | 05/22/2014SE |
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Questions and answers
When was TBL-ABI System cleared by the FDA?
TBL-ABI System (K173696) received a 510(k) decision of Substantially Equivalent on December 19, 2017, 18 days after the submission was received.
What is the product code of K173696?
The FDA product code is JOM – Plethysmograph, Photoelectric, Pneumatic Or Hydraulic, a Class II (moderate risk) device regulated under 21 CFR 870.2780.