# Pulse Oximeters for Medical Purposes - Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations: Draft Guidance for Industry and  Food and Drug Administration Staff – FDA Guidance

Source: https://www.keypedia.com/guidances/guidance-document/pulse-oximeters-for-medical-purposes-non-clinical-and-clinical-performance-testing-labeling-and-premarket-submission-recommendations-draft-guidance-for-industry-and-food-and-drug-administration-staff/0501096b-4fc1-492b-9162-43d891128680

> FDA guidance document: Pulse Oximeters for Medical Purposes - Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations: Draft Guidance for Industry and  Food and Drug Administration Staff. Issue date: January 07, 2025. Get complete insights and analysis.

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## Details

- Title: Pulse Oximeters for Medical Purposes - Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations: Draft Guidance for Industry and  Food and Drug Administration Staff
- Communication Type: Guidance Document
- Product Type: devices
- Office Name: Center for Devices and Radiological Health
- Office URL: /offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7
- Issue Date: 2025-01-07
- Comment Close Date: 2025-03-10
- Last Changed: 2025-06-04
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2023-N-4976">FDA-2023-N-4976</a>

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