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FDA 510(k)

PURITAN-BENNETT COMPANION 320 I/E BI-LEVEL RESPIRATORY SYSTEM

K-Number: K935784 · 1994-07-13

ApplicantPuritan-Bennett
Decision Date1994-07-13
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PURITAN-BENNETT COMPANION 320 I/E BI-LEVEL RESPIRATORY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Puritan-Bennett. It received FDA 510(k) clearance on 1994-07-13 under 510(k) number K935784. 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 BI-LEVEL RESPIRATORY SYSTEM?

PURITAN-BENNETT COMPANION 320 I/E BI-LEVEL RESPIRATORY SYSTEM is a medical device that received FDA 510(k) clearance on 1994-07-13. The listed applicant is Puritan-Bennett. The 510(k) number is K935784.

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

PURITAN-BENNETT COMPANION 320 I/E BI-LEVEL RESPIRATORY SYSTEM received FDA 510(k) clearance on 1994-07-13, under 510(k) number K935784.

Who is the listed applicant for PURITAN-BENNETT COMPANION 320 I/E BI-LEVEL RESPIRATORY SYSTEM?

The FDA 510(k) record lists Puritan-Bennett 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 BI-LEVEL RESPIRATORY SYSTEM?

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

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 Puritan-Bennett 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.

K021573PURITAN-BENNETT 840 VENTILATIOR SYSTEM WITH VOLUME VENTILATION PLUS OPTIONK943617DISPOSABLE MANUAL RESUSCITATORK942246PURITAN-BENNETT NASAL CPAP MASK

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

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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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