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FDA 510(k)

VENTI-MONITOR MODEL 101

K-Number: K812041 · 1981-09-25

ApplicantMedix Medical Electronics (U.S.A.), Inc.
Decision Date1981-09-25
Product CodeCAP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VENTI-MONITOR MODEL 101 is the device name listed in this FDA 510(k) record. The listed applicant is Medix Medical Electronics (U.S.A.), Inc.. It received FDA 510(k) clearance on 1981-09-25 under 510(k) number K812041. The device is classified under product code CAP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENTI-MONITOR MODEL 101?

VENTI-MONITOR MODEL 101 is a medical device that received FDA 510(k) clearance on 1981-09-25. The listed applicant is Medix Medical Electronics (U.S.A.), Inc.. The 510(k) number is K812041.

When did VENTI-MONITOR MODEL 101 receive FDA 510(k) clearance?

VENTI-MONITOR MODEL 101 received FDA 510(k) clearance on 1981-09-25, under 510(k) number K812041.

Who is the listed applicant for VENTI-MONITOR MODEL 101?

The FDA 510(k) record lists Medix Medical Electronics (U.S.A.), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VENTI-MONITOR MODEL 101?

The FDA product code for VENTI-MONITOR MODEL 101 is CAP.

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Other records listing Medix Medical Electronics (U.S.A.), Inc. 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.

K861040ENTERNAL INFUSER MULTIPUMP 203K861001PARENTERAL INFUSER MEDIPUMP 204K853393INSULIN PUMP INSUMAT 229K852433INFUSAFE 205 CATOLOG NO. 205.000K813562SYRINGE DRIVER 209K812039SPIROMETER 210/211

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Related Devices (Code: CAP)

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.

K201666SINGLE USE MANOMETERFlexicare Medical Limited.K182292VORTRAN APM-PlusVortran Medical Technology 1, Inc.K180510NS 120P-TRS Airway Pressure GaugeInstrumentation Industries, Inc.K172284NAPA LP-15 Airway Pressure MonitorDrw Medical, LLCK153733VORTRAN ManometerVortran Medical Technology 1, Inc.K122627GIO DIGITAL PRESSURE GUAGESGalemed Corp.

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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