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)

MODEL 120, OXYSOFT, INFRARED DATA CONVERTER, MODEL 120

K-Number: K002787 · 2000-11-29

ApplicantPalco Labs, Inc.
Decision Date2000-11-29
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 120, OXYSOFT, INFRARED DATA CONVERTER, MODEL 120 is the device name listed in this FDA 510(k) record. The listed applicant is Palco Labs, Inc.. It received FDA 510(k) clearance on 2000-11-29 under 510(k) number K002787. 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 MODEL 120, OXYSOFT, INFRARED DATA CONVERTER, MODEL 120?

MODEL 120, OXYSOFT, INFRARED DATA CONVERTER, MODEL 120 is a medical device that received FDA 510(k) clearance on 2000-11-29. The listed applicant is Palco Labs, Inc.. The 510(k) number is K002787.

When did MODEL 120, OXYSOFT, INFRARED DATA CONVERTER, MODEL 120 receive FDA 510(k) clearance?

MODEL 120, OXYSOFT, INFRARED DATA CONVERTER, MODEL 120 received FDA 510(k) clearance on 2000-11-29, under 510(k) number K002787.

Who is the listed applicant for MODEL 120, OXYSOFT, INFRARED DATA CONVERTER, MODEL 120?

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

What is the FDA product code for MODEL 120, OXYSOFT, INFRARED DATA CONVERTER, MODEL 120?

The FDA product code for MODEL 120, OXYSOFT, INFRARED DATA CONVERTER, MODEL 120 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 Palco Labs, 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.

K994372MODEL 120

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.

↑