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)

OC-100 OXIMETER INTERFACE CALIBRATOR

K-Number: K884891 · 1988-12-28

ApplicantTelediagnostic Systems, Inc.
Decision Date1988-12-28
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OC-100 OXIMETER INTERFACE CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Telediagnostic Systems, Inc.. It received FDA 510(k) clearance on 1988-12-28 under 510(k) number K884891. 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 OC-100 OXIMETER INTERFACE CALIBRATOR?

OC-100 OXIMETER INTERFACE CALIBRATOR is a medical device that received FDA 510(k) clearance on 1988-12-28. The listed applicant is Telediagnostic Systems, Inc.. The 510(k) number is K884891.

When did OC-100 OXIMETER INTERFACE CALIBRATOR receive FDA 510(k) clearance?

OC-100 OXIMETER INTERFACE CALIBRATOR received FDA 510(k) clearance on 1988-12-28, under 510(k) number K884891.

Who is the listed applicant for OC-100 OXIMETER INTERFACE CALIBRATOR?

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

What is the FDA product code for OC-100 OXIMETER INTERFACE CALIBRATOR?

The FDA product code for OC-100 OXIMETER INTERFACE CALIBRATOR 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 Telediagnostic 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.

K071661ALPHAONE BIOFEEDBACK SYSTEMK022249NIGHTRON POLYSOMNOGRAPHY SYSTEMK970659DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVERK904328VISTA POLYSOMNOGRAPHY COMPUTER SYSTEMK904222VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIERK885328RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVER

View all 14 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.

↑