FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Informed Vital Core Application (IVC App)
K Number: K241633
·
Decision Nov 18, 2024
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
12
Applicant Total
2
Review Days
165
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Basic Information
- Device Name
- Informed Vital Core Application (IVC App)
- K Number
- K241633
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2785
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mindset Medical, Inc.
- Date Received
- June 6, 2024
- Decision Date
- November 18, 2024
- Product Code
- QME
- 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 |
|---|---|---|---|
| QME | Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QME), ordered by most recent decision date.
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PanopticAI Vital Signs (1.6.1-22)
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FDA Class 2
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FDA 510(k)
FDA Class 2
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Vital Signs
FDA 510(k)
FDA Class 2
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Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Mindset Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K250078 | Informed Vital Core Application (IVC App) (v2.0.0.2.0.0) | May 30, 2025 | Substantially Equivalent |