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FDA 510(k)

COMPANION 800 PORTABLE NEBULIZER COMPRESSOR (C800)

K-Number: K921809 · 1992-12-04

ApplicantPuritan Bennett Corp.
Decision Date1992-12-04
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

COMPANION 800 PORTABLE NEBULIZER COMPRESSOR (C800) is the device name listed in this FDA 510(k) record. The listed applicant is Puritan Bennett Corp.. It received FDA 510(k) clearance on 1992-12-04 under 510(k) number K921809. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPANION 800 PORTABLE NEBULIZER COMPRESSOR (C800)?

COMPANION 800 PORTABLE NEBULIZER COMPRESSOR (C800) is a medical device that received FDA 510(k) clearance on 1992-12-04. The listed applicant is Puritan Bennett Corp.. The 510(k) number is K921809.

When did COMPANION 800 PORTABLE NEBULIZER COMPRESSOR (C800) receive FDA 510(k) clearance?

COMPANION 800 PORTABLE NEBULIZER COMPRESSOR (C800) received FDA 510(k) clearance on 1992-12-04, under 510(k) number K921809.

Who is the listed applicant for COMPANION 800 PORTABLE NEBULIZER COMPRESSOR (C800)?

The FDA 510(k) record lists Puritan Bennett Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMPANION 800 PORTABLE NEBULIZER COMPRESSOR (C800)?

The FDA product code for COMPANION 800 PORTABLE NEBULIZER COMPRESSOR (C800) is CAF.

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Other records listing Puritan Bennett Corp. 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.

K063650VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840K053388MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTIONK023225PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWAREK022103PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEMK001646PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTIONK002001BREEZE SLEEPGEAR WITH DREAMSEAL

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Related Devices (Code: CAF)

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.

K254171Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)Shenzhen Mericonn Technology Co., Ltd.K260270FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)FindAir Sp. z o.o.K251572eRapid with eTrack SystemPari Respiratory Equipment, Inc.K251659Mesh Nebulizer (H6)Qingdao Future Medical Technology Co., Ltd.K244035Portable mesh nebulizer (JM821)Shenzhen Jermei Medical Device Technology Co., Ltd.K243468Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)Joytech Healthcare Co. , Ltd.

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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