FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELECTRO SENSOR COMPLEX SOFTWARE (ES COMPLEX SOFTWARE)
K Number: K113264
·
Decision Mar 2, 2012
Classifications
1
FEI Numbers
428
Registration Numbers
428
Same Product Code
1216
Applicant Total
14
Review Days
119
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ELECTRO SENSOR COMPLEX SOFTWARE (ES COMPLEX SOFTWARE)
- K Number
- K113264
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ld Technology, LLC
- Date Received
- November 4, 2011
- Decision Date
- March 2, 2012
- Product Code
- DXN
- 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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DXN), ordered by most recent decision date.
Wrist Blood Pressure Monitor (XW-05)
FDA 510(k)
FDA Class 2
·Cardiovascular
VicorderCS (VCS-SYS-1100)
FDA 510(k)
FDA Class 2
·Cardiovascular
Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)
FDA 510(k)
FDA Class 2
·Cardiovascular
Upper arm electronic blood pressure monitor (XB-01)
FDA 510(k)
FDA Class 2
·Cardiovascular
Blood Pressure Monitor (W06LT)
FDA 510(k)
FDA Class 2
·Cardiovascular
Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)
FDA 510(k)
FDA Class 2
·Cardiovascular
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 |
| K160956 | LD-Oxi system | Jul 6, 2016 | 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 |
| K103026 | ELECTRO SENSOR -BODY COMPOSITION | Mar 29, 2011 | Substantially Equivalent |