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FDA 510(k)

AMBU CPAP SYSTEM

K-Number: K851194 · 1985-04-15

ApplicantAmbu, Inc.
Decision Date1985-04-15
Product CodeBYE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AMBU CPAP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ambu, Inc.. It received FDA 510(k) clearance on 1985-04-15 under 510(k) number K851194. The device is classified under product code BYE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMBU CPAP SYSTEM?

AMBU CPAP SYSTEM is a medical device that received FDA 510(k) clearance on 1985-04-15. The listed applicant is Ambu, Inc.. The 510(k) number is K851194.

When did AMBU CPAP SYSTEM receive FDA 510(k) clearance?

AMBU CPAP SYSTEM received FDA 510(k) clearance on 1985-04-15, under 510(k) number K851194.

Who is the listed applicant for AMBU CPAP SYSTEM?

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 CPAP SYSTEM?

The FDA product code for AMBU CPAP SYSTEM is BYE.

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 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: BYE)

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.

K160112Besmed PEEP ValveBesmed Health Business CorpK122610PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIESSen MU Technology Co., Ltd.K112546O_TWO CPAP SYSTEMO-Two Medical Technologies, Inc.K110713WATERPAP VALVEAirways Development, LLCK103833NEOPIP PATIENT CIRCUIT WITH PEEPNeoforce Group, Inc.K092029VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310Draeger Medical AG & Co. KG

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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