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FDA 510(k)

PRIMA OXYGEN MONITOR

K-Number: K010318 · 2001-07-23

ApplicantPenlon , Ltd.
Decision Date2001-07-23
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PRIMA OXYGEN MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Penlon , Ltd.. It received FDA 510(k) clearance on 2001-07-23 under 510(k) number K010318. 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 PRIMA OXYGEN MONITOR?

PRIMA OXYGEN MONITOR is a medical device that received FDA 510(k) clearance on 2001-07-23. The listed applicant is Penlon , Ltd.. The 510(k) number is K010318.

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

PRIMA OXYGEN MONITOR received FDA 510(k) clearance on 2001-07-23, under 510(k) number K010318.

Who is the listed applicant for PRIMA OXYGEN MONITOR?

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

What is the FDA product code for PRIMA OXYGEN MONITOR?

The FDA product code for PRIMA OXYGEN MONITOR is CCL.

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Other records listing Penlon , Ltd. 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.

K061102PRIMA ANAESTHESIA MACHINEK041076DELTA TK010317AV 800 VENTILATORK002343SIGMA DELTAK961468QUIK-FIL VAPORIZER KEYED FILLERK960944PPV VAPORIZER (MODIFICATION)

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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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