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FDA 510(k)

FI02 SENSING MODULE

K-Number: K944120 · 1995-05-10

ApplicantCore-M, L.P.
Decision Date1995-05-10
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FI02 SENSING MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Core-M, L.P.. It received FDA 510(k) clearance on 1995-05-10 under 510(k) number K944120. 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 FI02 SENSING MODULE?

FI02 SENSING MODULE is a medical device that received FDA 510(k) clearance on 1995-05-10. The listed applicant is Core-M, L.P.. The 510(k) number is K944120.

When did FI02 SENSING MODULE receive FDA 510(k) clearance?

FI02 SENSING MODULE received FDA 510(k) clearance on 1995-05-10, under 510(k) number K944120.

Who is the listed applicant for FI02 SENSING MODULE?

The FDA 510(k) record lists Core-M, L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FI02 SENSING MODULE?

The FDA product code for FI02 SENSING MODULE is CCL.

Related Clinical Trials

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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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