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FDA 510(k)

AMBU DISPOSABLE PRESSURE MANOMETER

K-Number: K040991 · 2004-07-22

ApplicantAmbu, Inc.
Decision Date2004-07-22
Product CodeCAP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AMBU DISPOSABLE PRESSURE MANOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Ambu, Inc.. It received FDA 510(k) clearance on 2004-07-22 under 510(k) number K040991. 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 AMBU DISPOSABLE PRESSURE MANOMETER?

AMBU DISPOSABLE PRESSURE MANOMETER is a medical device that received FDA 510(k) clearance on 2004-07-22. The listed applicant is Ambu, Inc.. The 510(k) number is K040991.

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

AMBU DISPOSABLE PRESSURE MANOMETER received FDA 510(k) clearance on 2004-07-22, under 510(k) number K040991.

Who is the listed applicant for AMBU DISPOSABLE PRESSURE MANOMETER?

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

What is the FDA product code for AMBU DISPOSABLE PRESSURE MANOMETER?

The FDA product code for AMBU DISPOSABLE PRESSURE MANOMETER is CAP.

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Other records listing Ambu, 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.

K051529AMBU NEUROLINE GROUNDK042682AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATORK042843AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORSK041734AMBU DISPOSABLE ECG ELECTRODEK041026AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-SK032278AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE

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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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