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FDA 510(k)

CPAP SYSTEM AND BRONCHO-CATH W/CPAP SYSTEM

K-Number: K912240 · 1991-08-22

ApplicantMallinckrodt Anesthesia Products
Decision Date1991-08-22
Product CodeBYE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CPAP SYSTEM AND BRONCHO-CATH W/CPAP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Anesthesia Products. It received FDA 510(k) clearance on 1991-08-22 under 510(k) number K912240. 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 CPAP SYSTEM AND BRONCHO-CATH W/CPAP SYSTEM?

CPAP SYSTEM AND BRONCHO-CATH W/CPAP SYSTEM is a medical device that received FDA 510(k) clearance on 1991-08-22. The listed applicant is Mallinckrodt Anesthesia Products. The 510(k) number is K912240.

When did CPAP SYSTEM AND BRONCHO-CATH W/CPAP SYSTEM receive FDA 510(k) clearance?

CPAP SYSTEM AND BRONCHO-CATH W/CPAP SYSTEM received FDA 510(k) clearance on 1991-08-22, under 510(k) number K912240.

Who is the listed applicant for CPAP SYSTEM AND BRONCHO-CATH W/CPAP SYSTEM?

The FDA 510(k) record lists Mallinckrodt Anesthesia Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CPAP SYSTEM AND BRONCHO-CATH W/CPAP SYSTEM?

The FDA product code for CPAP SYSTEM AND BRONCHO-CATH W/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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Mallinckrodt Anesthesia Products 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.

K895875MODEL 4070 TEMPERATURE MONITORK890484HI-LO TEMP GENERAL PURPOSE TEMPERATURE PROBE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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