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FDA 510(k)

BIO-TEK PERCENT OXYGEN MONITOR 74222

K-Number: K831522 · 1983-09-12

ApplicantBio-Tek Instruments, Inc.
Decision Date1983-09-12
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BIO-TEK PERCENT OXYGEN MONITOR 74222 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Tek Instruments, Inc.. It received FDA 510(k) clearance on 1983-09-12 under 510(k) number K831522. 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 BIO-TEK PERCENT OXYGEN MONITOR 74222?

BIO-TEK PERCENT OXYGEN MONITOR 74222 is a medical device that received FDA 510(k) clearance on 1983-09-12. The listed applicant is Bio-Tek Instruments, Inc.. The 510(k) number is K831522.

When did BIO-TEK PERCENT OXYGEN MONITOR 74222 receive FDA 510(k) clearance?

BIO-TEK PERCENT OXYGEN MONITOR 74222 received FDA 510(k) clearance on 1983-09-12, under 510(k) number K831522.

Who is the listed applicant for BIO-TEK PERCENT OXYGEN MONITOR 74222?

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

What is the FDA product code for BIO-TEK PERCENT OXYGEN MONITOR 74222?

The FDA product code for BIO-TEK PERCENT OXYGEN MONITOR 74222 is CCL.

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Other records listing Bio-Tek Instruments, Inc. as applicant

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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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