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)

NEOCARE OXYGEN MONITOR

K-Number: K810571 · 1981-03-11

ApplicantVickers America Medical Corp.
Decision Date1981-03-11
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NEOCARE OXYGEN MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Vickers America Medical Corp.. It received FDA 510(k) clearance on 1981-03-11 under 510(k) number K810571. The device is classified under product code CCL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEOCARE OXYGEN MONITOR?

NEOCARE OXYGEN MONITOR is a medical device that received FDA 510(k) clearance on 1981-03-11. The listed applicant is Vickers America Medical Corp.. The 510(k) number is K810571.

When did NEOCARE OXYGEN MONITOR receive FDA 510(k) clearance?

NEOCARE OXYGEN MONITOR received FDA 510(k) clearance on 1981-03-11, under 510(k) number K810571.

Who is the listed applicant for NEOCARE OXYGEN MONITOR?

The FDA 510(k) record lists Vickers America Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEOCARE OXYGEN MONITOR?

The FDA product code for NEOCARE OXYGEN MONITOR is CCL.

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 Vickers America Medical Corp. 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.

K840823TREONIC C30K831838LABORATORY DATA MGMT SYSTEM SDMSK830748RESUSCITAIREK830936TREONIC IP5K813239OXYGENAIRE NURING INCUBATORK813238NEOCARE BABY-CONTROLLED INCUBATOR

View all 22 devices →

Related Devices (Code: CCL)

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.

K261389PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)Salter LabsK251245OxyMinder Pro (10310)Bio-Med Device, Inc.K250002Smart Check O2 (MA0236)Life Spark Medical, LLCK221734Maxtec MaxO2 ME+pMaxtec, LLCK213933Percent Oxygen SensorsCareox, LLCK213948OxyMinderBio-Med Devices, 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.

↑