FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MoMe Software Platform
K Number: K152491
·
Decision Dec 17, 2015
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
397
Applicant Total
5
Review Days
107
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Basic Information
- Device Name
- MoMe Software Platform
- K Number
- K152491
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Infobionic, Inc.
- Date Received
- September 1, 2015
- Decision Date
- December 17, 2015
- Product Code
- DSI
- 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 |
|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | FDA class 2 | Cardiovascular |
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Other Clearances by Infobionic, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K250356 | MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) | Jul 29, 2025 | Substantially Equivalent |
| K230265 | MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System | Oct 6, 2023 | Substantially Equivalent |
| K160064 | MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System | Mar 11, 2016 | Substantially Equivalent |
| K133753 | MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR | Sep 19, 2014 | Substantially Equivalent |