Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

503 PULSE OXIMETER

K-Number: K911124 · 1991-06-07

ApplicantCriticare Systems, Inc.
Decision Date1991-06-07
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

503 PULSE OXIMETER is the device name listed in this FDA 510(k) record. The listed applicant is Criticare Systems, Inc.. It received FDA 510(k) clearance on 1991-06-07 under 510(k) number K911124. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 503 PULSE OXIMETER?

503 PULSE OXIMETER is a medical device that received FDA 510(k) clearance on 1991-06-07. The listed applicant is Criticare Systems, Inc.. The 510(k) number is K911124.

When did 503 PULSE OXIMETER receive FDA 510(k) clearance?

503 PULSE OXIMETER received FDA 510(k) clearance on 1991-06-07, under 510(k) number K911124.

Who is the listed applicant for 503 PULSE OXIMETER?

The FDA 510(k) record lists Criticare Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 503 PULSE OXIMETER?

The FDA product code for 503 PULSE OXIMETER is DQA.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Criticare Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K101602VITAL SIGNS MONITORK091050506CN PATIENT MONITORK0425698600 VITAL SIGNS MONITORK030613VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100K022435507EL VITAL SIGNS MONITORK0120598100/8500 VITAL SIGNS MONITOR

View all 22 devices →

Related Devices (Code: DQA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbHK252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd.K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)Philips Medizin SystemeK260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Pulse Oximeter (SP61)Avita CorporationK252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑