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FDA 510(k)

VENTRONICS #5590 ECII OXYGEN MONITOR

K-Number: K812854 · 1981-11-06

ApplicantVentronics, Div of Hudson Oxygen Therapy Sales Co.
Decision Date1981-11-06
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VENTRONICS #5590 ECII OXYGEN MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Ventronics, Div of Hudson Oxygen Therapy Sales Co.. It received FDA 510(k) clearance on 1981-11-06 under 510(k) number K812854. 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 VENTRONICS #5590 ECII OXYGEN MONITOR?

VENTRONICS #5590 ECII OXYGEN MONITOR is a medical device that received FDA 510(k) clearance on 1981-11-06. The listed applicant is Ventronics, Div of Hudson Oxygen Therapy Sales Co.. The 510(k) number is K812854.

When did VENTRONICS #5590 ECII OXYGEN MONITOR receive FDA 510(k) clearance?

VENTRONICS #5590 ECII OXYGEN MONITOR received FDA 510(k) clearance on 1981-11-06, under 510(k) number K812854.

Who is the listed applicant for VENTRONICS #5590 ECII OXYGEN MONITOR?

The FDA 510(k) record lists Ventronics, Div of Hudson Oxygen Therapy Sales Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VENTRONICS #5590 ECII OXYGEN MONITOR?

The FDA product code for VENTRONICS #5590 ECII OXYGEN MONITOR is CCL.

Related Clinical Trials

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.

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Other records listing Ventronics, Div of Hudson Oxygen Therapy Sales Co. 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.

K812855VENTRONICS #5595 ECII OXYGEN ANALYZER

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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