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)

HANDHELD PULSE OXIMETER MODEL M800

K-Number: K101694 · 2010-09-08

ApplicantGuangdong Biolight Meditech Co., Ltd.
Decision Date2010-09-08
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HANDHELD PULSE OXIMETER MODEL M800 is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Biolight Meditech Co., Ltd.. It received FDA 510(k) clearance on 2010-09-08 under 510(k) number K101694. 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 HANDHELD PULSE OXIMETER MODEL M800?

HANDHELD PULSE OXIMETER MODEL M800 is a medical device that received FDA 510(k) clearance on 2010-09-08. The listed applicant is Guangdong Biolight Meditech Co., Ltd.. The 510(k) number is K101694.

When did HANDHELD PULSE OXIMETER MODEL M800 receive FDA 510(k) clearance?

HANDHELD PULSE OXIMETER MODEL M800 received FDA 510(k) clearance on 2010-09-08, under 510(k) number K101694.

Who is the listed applicant for HANDHELD PULSE OXIMETER MODEL M800?

The FDA 510(k) record lists Guangdong Biolight Meditech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HANDHELD PULSE OXIMETER MODEL M800?

The FDA product code for HANDHELD PULSE OXIMETER MODEL M800 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 Guangdong Biolight Meditech Co., Ltd. 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.

K181919Patient MonitorK170514Central Monitoring SystemK162234Truscope Ultra Patient MonitorK160349Electronic SphygmomanometerK153580Central Monitoring SystemK153135VITAL SIGNS MONITOR

View all 17 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.

↑