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FDA 510(k)

MONITOR, OXYCHEK OXYGEN

K-Number: K782114 · 1979-01-18

ApplicantCritikon Company, LLC
Decision Date1979-01-18
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MONITOR, OXYCHEK OXYGEN is the device name listed in this FDA 510(k) record. The listed applicant is Critikon Company, LLC. It received FDA 510(k) clearance on 1979-01-18 under 510(k) number K782114. 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 MONITOR, OXYCHEK OXYGEN?

MONITOR, OXYCHEK OXYGEN is a medical device that received FDA 510(k) clearance on 1979-01-18. The listed applicant is Critikon Company, LLC. The 510(k) number is K782114.

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

MONITOR, OXYCHEK OXYGEN received FDA 510(k) clearance on 1979-01-18, under 510(k) number K782114.

Who is the listed applicant for MONITOR, OXYCHEK OXYGEN?

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

What is the FDA product code for MONITOR, OXYCHEK OXYGEN?

The FDA product code for MONITOR, OXYCHEK OXYGEN is CCL.

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Other records listing Critikon Company, LLC 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.

K002248DINAMAP PRO 1000 MONITOR, MODEL 1000K000500DINAMAP ADVANCED NIBP MODULEK992638DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400K982342DINAMAP MPS SELECT PORTABLE MONITORK943709DINAMAP PLUS VITAL SIGNS MONOITORK942700DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340

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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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