FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
Oxehealth Vital Signs
K Number: K220899
·
Decision Apr 29, 2022
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
12
Applicant Total
6
Review Days
32
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Basic Information
- Device Name
- Oxehealth Vital Signs
- K Number
- K220899
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.2785
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Oxehealth Limited
- Date Received
- March 28, 2022
- Decision Date
- April 29, 2022
- 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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FDA 510(k)
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FDA 510(k)
FDA Class 2
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Other Clearances by Oxehealth Limited
| K Number | Device Name | ||
|---|---|---|---|
| K251200 | Vital Signs | Feb 2, 2026 | Substantially Equivalent |
| K243687 | Vital Signs | Aug 27, 2025 | Substantially Equivalent |
| K233618 | Oxevision Sleep Device | Apr 3, 2024 | Substantially Equivalent |
| K211906 | Vital Signs | Jul 20, 2021 | Substantially Equivalent |
| DEN200019 | Oxehealth Vital Signs | Mar 26, 2021 | Unknown |