FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM
K Number: K124060
·
Decision Feb 21, 2013
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
397
Applicant Total
11
Review Days
52
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Basic Information
- Device Name
- MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM
- K Number
- K124060
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medicalgorithmics S.A.
- Date Received
- December 31, 2012
- Decision Date
- February 21, 2013
- 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 Medicalgorithmics S.A.
| K Number | Device Name | ||
|---|---|---|---|
| K253141 | DeepRhythmAI | Dec 11, 2025 | Substantially Equivalent |
| K250932 | DeepRhythmAI | May 27, 2025 | Substantially Equivalent |
| K241197 | DeepRhythmAI | Dec 4, 2024 | Substantially Equivalent |
| K232161 | DeepRhythm Platform | Jun 20, 2024 | Substantially Equivalent |
| K210822 | DeepRhythmAI | Jul 27, 2022 | Substantially Equivalent |
| K210758 | Q Patch | Jun 2, 2022 | Substantially Equivalent |
| K193104 | Unified Arrhythmia Diagnostic System PocketECG IV | Apr 9, 2020 | Substantially Equivalent |
| K173969 | Medicalgorithmics Unified Cardiac Rehabilitation System | Jul 11, 2018 | Substantially Equivalent |
| K152550 | MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM | Oct 8, 2015 | Substantially Equivalent |
| K112921 | MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM | May 16, 2012 | Substantially Equivalent |