Vital Signs— 510(k) K243687
Substantially EquivalentOxehealth Limited
FDA 510(k) clearance K243687 for Vital Signs, Substantially Equivalent on 2025-08-27. Applicant: Oxehealth Limited. Device class: 2.
Clearance details
- Applicant
- Oxehealth Limited
- Product code
- Code QME
- Device class
- Class 2
- Regulation
- 21 CFR 870.2785
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Abingdon, GB
Recent devices under product code QME
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