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FDA 510(k)

DRAGER PRESSURE MONITOR, SELF-DIAGNOSTIC

K-Number: K802090 · 1980-09-26

ApplicantDraeger Medical, Inc.
Decision Date1980-09-26
Product CodeCAP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DRAGER PRESSURE MONITOR, SELF-DIAGNOSTIC is the device name listed in this FDA 510(k) record. The listed applicant is Draeger Medical, Inc.. It received FDA 510(k) clearance on 1980-09-26 under 510(k) number K802090. 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 DRAGER PRESSURE MONITOR, SELF-DIAGNOSTIC?

DRAGER PRESSURE MONITOR, SELF-DIAGNOSTIC is a medical device that received FDA 510(k) clearance on 1980-09-26. The listed applicant is Draeger Medical, Inc.. The 510(k) number is K802090.

When did DRAGER PRESSURE MONITOR, SELF-DIAGNOSTIC receive FDA 510(k) clearance?

DRAGER PRESSURE MONITOR, SELF-DIAGNOSTIC received FDA 510(k) clearance on 1980-09-26, under 510(k) number K802090.

Who is the listed applicant for DRAGER PRESSURE MONITOR, SELF-DIAGNOSTIC?

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

What is the FDA product code for DRAGER PRESSURE MONITOR, SELF-DIAGNOSTIC?

The FDA product code for DRAGER PRESSURE MONITOR, SELF-DIAGNOSTIC is CAP.

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Other records listing Draeger Medical, 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.

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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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