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FDA 510(k)

100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I

K-Number: K010382 · 2001-03-01

ApplicantSensidyne, Inc.
Decision Date2001-03-01
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I is the device name listed in this FDA 510(k) record. The listed applicant is Sensidyne, Inc.. It received FDA 510(k) clearance on 2001-03-01 under 510(k) number K010382. 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 100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I?

100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I is a medical device that received FDA 510(k) clearance on 2001-03-01. The listed applicant is Sensidyne, Inc.. The 510(k) number is K010382.

When did 100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I receive FDA 510(k) clearance?

100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I received FDA 510(k) clearance on 2001-03-01, under 510(k) number K010382.

Who is the listed applicant for 100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I?

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 100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I?

The FDA product code for 100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I 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.

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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-BC150-3K011974SENSAIDK000700SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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