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FDA 510(k)

MONITOR, OXYGEN, MODEL 3000A

K-Number: K781209 · 1978-08-14

ApplicantOxyair Engineering, Inc.
Decision Date1978-08-14
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MONITOR, OXYGEN, MODEL 3000A is the device name listed in this FDA 510(k) record. The listed applicant is Oxyair Engineering, Inc.. It received FDA 510(k) clearance on 1978-08-14 under 510(k) number K781209. 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, OXYGEN, MODEL 3000A?

MONITOR, OXYGEN, MODEL 3000A is a medical device that received FDA 510(k) clearance on 1978-08-14. The listed applicant is Oxyair Engineering, Inc.. The 510(k) number is K781209.

When did MONITOR, OXYGEN, MODEL 3000A receive FDA 510(k) clearance?

MONITOR, OXYGEN, MODEL 3000A received FDA 510(k) clearance on 1978-08-14, under 510(k) number K781209.

Who is the listed applicant for MONITOR, OXYGEN, MODEL 3000A?

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

What is the FDA product code for MONITOR, OXYGEN, MODEL 3000A?

The FDA product code for MONITOR, OXYGEN, MODEL 3000A is CCL.

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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

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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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