FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PATIENT MONITOR
K Number: K130056
·
Decision Apr 11, 2013
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
301
Applicant Total
7
Review Days
92
Basic Information
- Device Name
- PATIENT MONITOR
- K Number
- K130056
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- LD TECHNOLOGY LLC
- Date Received
- January 9, 2013
- Decision Date
- April 11, 2013
- 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
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|---|---|---|---|
| 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 |
| K113264 | ELECTRO SENSOR COMPLEX SOFTWARE (ES COMPLEX SOFTWARE) | Mar 2, 2012 | Substantially Equivalent |