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FDA 510(k)

DISPOSABLE PRESSURE MONITOR

K-Number: K003497 · 2000-11-30

ApplicantEngineered Medical Systems
Decision Date2000-11-30
Product CodeCAP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE PRESSURE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Engineered Medical Systems. It received FDA 510(k) clearance on 2000-11-30 under 510(k) number K003497. 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 DISPOSABLE PRESSURE MONITOR?

DISPOSABLE PRESSURE MONITOR is a medical device that received FDA 510(k) clearance on 2000-11-30. The listed applicant is Engineered Medical Systems. The 510(k) number is K003497.

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

DISPOSABLE PRESSURE MONITOR received FDA 510(k) clearance on 2000-11-30, under 510(k) number K003497.

Who is the listed applicant for DISPOSABLE PRESSURE MONITOR?

The FDA 510(k) record lists Engineered Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE PRESSURE MONITOR?

The FDA product code for DISPOSABLE PRESSURE MONITOR is CAP.

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Related Devices (Code: CAP)

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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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