FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LD-Oxi system
K Number: K160956
·
Decision Jul 6, 2016
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
305
Applicant Total
14
Review Days
92
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Basic Information
- Device Name
- LD-Oxi system
- K Number
- K160956
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ld Technology, LLC
- Date Received
- April 5, 2016
- Decision Date
- July 6, 2016
- Product Code
- MWI
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | FDA class 2 | Cardiovascular |
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Other Clearances by Ld Technology, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K200287 | BP-BT Kiosk | May 15, 2020 | Substantially Equivalent |
| K200141 | Oxi-W System | Apr 27, 2020 | Substantially Equivalent |
| K173696 | TBL-ABI System | Dec 19, 2017 | Substantially Equivalent |
| K152216 | SudoC | Sep 24, 2015 | Substantially Equivalent |
| K143152 | TM-ABI system | Jul 22, 2015 | Substantially Equivalent |
| K140412 | ANS1 SOFTWARE | May 22, 2014 | Substantially Equivalent |
| K131568 | SUDO PATH | Jun 28, 2013 | Substantially Equivalent |
| K130056 | PATIENT MONITOR | Apr 11, 2013 | Substantially Equivalent |
| K113264 | ELECTRO SENSOR COMPLEX SOFTWARE (ES COMPLEX SOFTWARE) | Mar 2, 2012 | Substantially Equivalent |
| K103026 | ELECTRO SENSOR -BODY COMPOSITION | Mar 29, 2011 | Substantially Equivalent |