FDA has developed this guidance document to assist industry in preparing premarket notifications (510(k)s) for pulse oximeters. These devices are intended for non-invasive measurement of the...

6 days ago · Oximeter: 510(k) Number: K090671: Device Name: PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D: Applicant

FDA has developed this guidance document to assist industry in preparing premarket notifications (510(k)s) for pulse oximeters.

Pulse oximeters are widely used by many types of healthcare providers and consumers to obtain an indirect measure (SpO2) of arterial blood oxygen saturation (SaO2). SaO2 measurement is...

Mar 4, 2013 · FDA has developed this guidance document to assist industry in preparing a Premarket Notification (510(k)) for a pulse oximeter. The device is intended for non-invasive measurement of SpO 2 and pulse rate.

Nov 30, 2024 · Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff. Download the Guidance Document

Mar 3, 2025 · 510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... Device Name: Masimo MightySat Rx Fingertip Pulse Oximeter: Applicant: Masimo Corporation: 52 Discovery: Irvine, CA 92618 Applicant Contact: Kelly Nguyen: Correspondent: Masimo Corporation: 52 Discovery: Irvine, CA ...

FDA premarket device registration for Pulse Oximeter, Models Cms50e, Cms50f, Cms60c, Cms60d distributed by CONTEC MEDICAL SYSTEM CO., LTD.

FDA premarket device registration for Checkme O2 Pulse Oximeter distributed by Shenzhen Viatom Technology Co., Ltd.

Jan 7, 2025 · This draft guidance document proposes recommendations regarding non-clinical and clinical performance testing of certain pulse oximeters for medical purposes, including devices with a pulse oximeter function that estimates …