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)

EAR OXIMETER

K-Number: K810363 · 1981-02-27

ApplicantBio-Tek Instruments, Inc.
Decision Date1981-02-27
Product CodeDPZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EAR OXIMETER is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Tek Instruments, Inc.. It received FDA 510(k) clearance on 1981-02-27 under 510(k) number K810363. The device is classified under product code DPZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EAR OXIMETER?

EAR OXIMETER is a medical device that received FDA 510(k) clearance on 1981-02-27. The listed applicant is Bio-Tek Instruments, Inc.. The 510(k) number is K810363.

When did EAR OXIMETER receive FDA 510(k) clearance?

EAR OXIMETER received FDA 510(k) clearance on 1981-02-27, under 510(k) number K810363.

Who is the listed applicant for EAR OXIMETER?

The FDA 510(k) record lists Bio-Tek Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EAR OXIMETER?

The FDA product code for EAR OXIMETER is DPZ.

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 Bio-Tek Instruments, 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.

K973609IDA-4 AND IPT-MCK971273INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EFK961862MODELS IDA-2 PLUS AND IPT-1K954391MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTERK953710ELX808 AUTOMATED MICROPLATE READERSK953572ELX800UV

View all 37 devices →

Related Devices (Code: DPZ)

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.

K042675FLEXI-STAT SP02 EAR SENSORElekon Industries U.S.A., Inc.K040831DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500Datex-Ohmeda, Inc.K012333FLEXI-SITE SP02 EAR SENSOREpic Medical Equipment Services, Inc.K010718FLEXI-SITE SP02 EAR SENSOREpic Medical Equipment Services, Inc.K944760DURA-Y OXYGEN TRANSDUCER, EAR CLIPNellcor, Inc.K942752MARQUETTE EAR PROBE SENSORMarquette Electronics, Inc.

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.

↑