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FDA 510(k)

AMBU TWIN PUMP - (MANUAL SUCTION PUMP)

K-Number: K883433 · 1988-09-02

ApplicantAmbu, Inc.
Decision Date1988-09-02
Product CodeGCY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AMBU TWIN PUMP - (MANUAL SUCTION PUMP) is the device name listed in this FDA 510(k) record. The listed applicant is Ambu, Inc.. It received FDA 510(k) clearance on 1988-09-02 under 510(k) number K883433. The device is classified under product code GCY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMBU TWIN PUMP - (MANUAL SUCTION PUMP)?

AMBU TWIN PUMP - (MANUAL SUCTION PUMP) is a medical device that received FDA 510(k) clearance on 1988-09-02. The listed applicant is Ambu, Inc.. The 510(k) number is K883433.

When did AMBU TWIN PUMP - (MANUAL SUCTION PUMP) receive FDA 510(k) clearance?

AMBU TWIN PUMP - (MANUAL SUCTION PUMP) received FDA 510(k) clearance on 1988-09-02, under 510(k) number K883433.

Who is the listed applicant for AMBU TWIN PUMP - (MANUAL SUCTION PUMP)?

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 TWIN PUMP - (MANUAL SUCTION PUMP)?

The FDA product code for AMBU TWIN PUMP - (MANUAL SUCTION PUMP) is GCY.

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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 ELECTRODEK040991AMBU DISPOSABLE PRESSURE MANOMETERK041026AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S

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Related Devices (Code: GCY)

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.

K972703REDYROB-CLOSED WOUND DRAINAGE SYSTEMB.Braun Medical, Inc.K971036ODONTIT AUTOGENOUS BONE COLLECTION DEVICEInterpore Intl.K963839CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500Cordis Corp.K960099PENROSE DRAIN MODELS 6001 - 6007Sil-Med Corp.K950754MACRO SUCTION TUBE MODEL NO 10061Dlp, Inc.K936223PRESSURE IRRIGATING SYSTEMLevel 1 Technologies, Inc.

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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