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FDA 510(k)

PURITAN-BENNETT COMPANION 320 I/E

K-Number: K934804 · 1995-02-27

ApplicantPuritan Bennett Corp.
Decision Date1995-02-27
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PURITAN-BENNETT COMPANION 320 I/E 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 1995-02-27 under 510(k) number K934804. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PURITAN-BENNETT COMPANION 320 I/E?

PURITAN-BENNETT COMPANION 320 I/E is a medical device that received FDA 510(k) clearance on 1995-02-27. The listed applicant is Puritan Bennett Corp.. The 510(k) number is K934804.

When did PURITAN-BENNETT COMPANION 320 I/E receive FDA 510(k) clearance?

PURITAN-BENNETT COMPANION 320 I/E received FDA 510(k) clearance on 1995-02-27, under 510(k) number K934804.

Who is the listed applicant for PURITAN-BENNETT COMPANION 320 I/E?

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 COMPANION 320 I/E?

The FDA product code for PURITAN-BENNETT COMPANION 320 I/E is BZD.

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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: BZD)

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.

K261262Altis Full Face MaskRespironics, Inc.K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.K253553OrionResmed CorpK254104ResScan EssentialsResmed CorpK251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face MaskDcstar, Inc.K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC 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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