# Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document Source: https://www.globalkeysolutions.net/guidances/guidance-document/pulse-oximeters-premarket-notification-submissions-510ks-guidance-for-industry-and-food-and-drug-administration-staff/be0145bd-7ce8-475d-a092-cc4cf7fef3f0 > FDA guidance document: Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff. Issue date: March 03, 2013. Get complete insights and analysis. --- ## Details - Title: Pulse Oximeters - Premarket Notification Submissions [510(k)s]: 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: 2013-03-03 - Last Changed: 2025-01-31 - Docket Number: FDA-2007-D-0205 ## Related Documents - [Premarket Notification [510(k)] Submissions for Chemical Indicators - Guidance for Industry and FDA Staff](https://www.globalkeysolutions.net/guidances/guidance-document/premarket-notification-510k-submissions-for-chemical-indicators-guidance-for-industry-and-fda-staff/ef44b29e-a196-4909-b62b-a28f805b7be2) - [Dental Handpieces - Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff](https://www.globalkeysolutions.net/guidances/guidance-document/dental-handpieces-premarket-notification-510k-submissions-guidance-for-industry-and-fda-staff/7aa25e62-346c-4cb8-9791-431db46c770d) - [Biological Indicator (BI) Premarket Notification [510(k)] Submissions : Guidance for Industry and FDA Staff](https://www.globalkeysolutions.net/guidances/guidance-document/biological-indicator-bi-premarket-notification-510k-submissions-guidance-for-industry-and-fda-staff/51018101-f28f-48a6-9a97-175cb14cee50)