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FDA 510(k)

SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR

K-Number: K000700 · 2000-08-31

ApplicantSensidyne, Inc.
Decision Date2000-08-31
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Sensidyne, Inc.. It received FDA 510(k) clearance on 2000-08-31 under 510(k) number K000700. 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 SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR?

SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR is a medical device that received FDA 510(k) clearance on 2000-08-31. The listed applicant is Sensidyne, Inc.. The 510(k) number is K000700.

When did SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR receive FDA 510(k) clearance?

SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR received FDA 510(k) clearance on 2000-08-31, under 510(k) number K000700.

Who is the listed applicant for SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR?

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

What is the FDA product code for SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR?

The FDA product code for SENSIDYNE OXYGEN ANALYZER & SENSIDYNE 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 Sensidyne, 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.

K021246SENSAID, MODELS# RC-NVA30-10; RC-CS140-10; RC-BC150-3K011974SENSAIDK010382100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I

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.

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