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FDA 510(k)

PURITAN-BENNETT 335 RESPIRATORY SUPPORT SYSTEM

K-Number: K942210 · 1996-02-09

ApplicantPuritan Bennett Corp.
Decision Date1996-02-09
Product CodeMNS
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PURITAN-BENNETT 335 RESPIRATORY SUPPORT SYSTEM 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 1996-02-09 under 510(k) number K942210. The device is classified under product code MNS. It was reviewed by the AN advisory panel. Product code MNS falls under the category of Neurology, which encompasses devices for neurological diagnosis and monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PURITAN-BENNETT 335 RESPIRATORY SUPPORT SYSTEM?

PURITAN-BENNETT 335 RESPIRATORY SUPPORT SYSTEM is a medical device that received FDA 510(k) clearance on 1996-02-09. The listed applicant is Puritan Bennett Corp.. The 510(k) number is K942210.

When did PURITAN-BENNETT 335 RESPIRATORY SUPPORT SYSTEM receive FDA 510(k) clearance?

PURITAN-BENNETT 335 RESPIRATORY SUPPORT SYSTEM received FDA 510(k) clearance on 1996-02-09, under 510(k) number K942210.

Who is the listed applicant for PURITAN-BENNETT 335 RESPIRATORY SUPPORT SYSTEM?

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 PURITAN-BENNETT 335 RESPIRATORY SUPPORT SYSTEM?

The FDA product code for PURITAN-BENNETT 335 RESPIRATORY SUPPORT SYSTEM is MNS. This falls under the Neurology category.

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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: MNS)

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.

K251889myAirResmed CorpK252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.K251661Mariana Minerva; Mariana NimbusResmed Pty , Ltd.K240778Vivo 1, Vivo 2Breas Medical ABK231064ReddyPort ElbowSmd Manufacturing, LLCK213169BPAP SystemBMC Medical 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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