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FDA 510(k)

MEAN PRESSURE MONITOR

K-Number: K810255 · 1981-02-12

ApplicantHealthdyne, Inc.
Decision Date1981-02-12
Product CodeCAP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MEAN PRESSURE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Healthdyne, Inc.. It received FDA 510(k) clearance on 1981-02-12 under 510(k) number K810255. 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 MEAN PRESSURE MONITOR?

MEAN PRESSURE MONITOR is a medical device that received FDA 510(k) clearance on 1981-02-12. The listed applicant is Healthdyne, Inc.. The 510(k) number is K810255.

When did MEAN PRESSURE MONITOR receive FDA 510(k) clearance?

MEAN PRESSURE MONITOR received FDA 510(k) clearance on 1981-02-12, under 510(k) number K810255.

Who is the listed applicant for MEAN PRESSURE MONITOR?

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

What is the FDA product code for MEAN PRESSURE MONITOR?

The FDA product code for MEAN PRESSURE MONITOR is CAP.

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 Healthdyne, 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.

K950331PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS)K922106ALICEK942357H-500 ALLIANCE OXYGEN CONCENTRATORK934502FLOW SPIROMETERK924146OH-500 OXYGEN CONCENTRATORK922623NEBULIZER SYSTEM

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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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